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We focus on access so you can focus on health Welcome to Genentech BioOncology™ Access Solutions.

Genentech BioOncology Access Solutions offers a full range of programs and services to meet the needs of eligible patients and health care professionals. We might be able to help patients with their access needs, from benefits investigations through patient assistance options for those who are eligible.

 


 

 

Infused Products


Oral Products


Indications and Important Safety Information

 

Avastin

What is Avastin approved for?

Glioblastoma (GBM)
Avastin is approved to treat glioblastoma (GBM) when taken alone in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM). The effectiveness of Avastin in rGBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people with rGBM.

Metastatic Colorectal Cancer (mCRC)
Avastin is approved to treat metastatic colorectal cancer (mCRC) for:

  • First- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy
  • Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin

Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

Non–Small Cell Lung Cancer (NSCLC)
Avastin, in combination with carboplatin and paclitaxel, is approved to treat advanced nonsquamous non–small cell lung cancer (NSCLC) in people who have not received chemotherapy for their advanced disease.

Metastatic Kidney Cancer (mRCC)
Avastin, used with interferon alfa, is approved to treat metastatic kidney cancer (mRCC).

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

  • Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include trouble breathing, chest pain, and sweating. Your doctor or nurse will monitor you for signs of infusion reactions
  • Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
  • A passage between two organs. This type of passage—known as a fistula—does not form normally and can sometimes be fatal
  • Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Rectal bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Avastin is not for everyone

Talk to your doctor if you are:

  • Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
  • Breast-feeding or pregnant. Avastin may harm a nursing child or a baby in the womb
  • Planning to become pregnant. Taking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children. If you stop Avastin, you should keep using birth control for at least 6 months before trying to become pregnant

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Product Information, including Serious Side Effects, for additional important safety information.

Avastin® and the Access Solutions logo are registered trademarks of Genentech, Inc.

Erivedge

INDICATION

Erivedge is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.

Serious Side Effects

Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

Important Safety Information

What is the most important information I should know about Erivedge?

  • Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects
  • For females who can become pregnant, talk with your healthcare provider about the risks of Erivedge to your unborn child. Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant. Avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for 7 months after your last dose. Tell your healthcare provider right away if you have unprotected sex or think that your birth control has failed
  • For males, always use a condom with a spermicide during sex with female partners while you are taking Erivedge and for 2 months after your last dose, even if you have had a vasectomy
  • Tell your healthcare provider right away if you or your female partner could be pregnant or thinks she is pregnant while you are taking Erivedge

Exposure to Erivedge during pregnancy:

Pregnant women are encouraged to participate in a program that collects information about exposure and the effects on the mother and her unborn child by calling the Genentech Adverse Event Line at (888) 835-2555.

What should I tell my healthcare provider before taking Erivedge?

  • If you are pregnant or plan to become pregnant
  • If you are breast-feeding or plan to breast-feed

What should I avoid while taking Erivedge?

Do not donate blood or blood products while you are taking Erivedge and for 7 months after your last dose.

What are the possible side effects of Erivedge?

The most common side effects of Erivedge are:

  • Muscle spasms
  • Hair loss
  • Change in how things taste or loss of taste
  • Weight loss
  • Tiredness
  • Nausea
  • Diarrhea
  • Decreased appetite
  • Constipation
  • Vomiting
  • Joint aches

These are not all of the possible side effects of Erivedge. For more information, ask your healthcare provider or pharmacist.

Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. If you have questions or concerns about side effects, you should talk to your doctor.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and the Medication Guide for serious side effects and additional important safety information.

GAZYVA

Indication

GAZYVA (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

 

IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have had hepatitis B or are a carrier of HBV, receiving GAZYVA could cause the virus to become an active infection again. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to monitor for hepatitis during and after your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening fatigue and yellow discoloration of skin or eyes
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus that can lead to severe disability and death. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

What are the additional possible serious side effects of GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion Reactions: GAZYVA can cause severe and life-threatening infusion reactions, including but not limited to severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If severe or life-threatening infusion reactions occur, your infusion will be stopped and you will not continue treatment with GAZYVA. Infusion reactions may occur during or within 24 hours of your infusion. Your doctor should give you medicines before your treatment that may help to reduce your risk of an infusion reaction. Other symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain
  • Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS may cause an abnormal heartbeat or kidney failure requiring the need for dialysis treatment. Your doctor may do blood tests to check you for TLS and give you medicines before your treatment to help prevent TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness
  • Infections: Serious bacterial, fungal, and viral infections can occur during and following GAZYVA therapy. Symptoms can include fever and cough. Patients with active infection should not be treated with GAZYVA. Patients with a history of recurring or chronic infections may be at increased risk of infection
  • Low White Blood Cell Count: When you have an abnormally low white blood cell count, it’s called neutropenia. White blood cells help fight infections. Neutropenia can occur during treatment with GAZYVA and more than 28 days after the end of treatment. It may also last for more than 28 days. While you are taking GAZYVA, your doctor will check your white blood cell count. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections
  • Low Platelet Count: When you have an abnormally low platelet count, it’s called thrombocytopenia. Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets you have in your blood. This may affect the clotting process. While you are taking GAZYVA, your doctor will monitor your platelet count

The most common side effects of GAZYVA are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, and muscle and joint pain.

What other information should I tell my doctor before receiving GAZYVA?

You should talk to your doctor about:

  • Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines
  • Pregnancy: Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if GAZYVA may harm your unborn baby or pass into your breast milk. You and your doctor should decide if you should discontinue GAZYVA or discontinue breastfeeding. Women should use birth control while using GAZYVA and for 12 months after treatment

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.

GAZYVA is available by prescription only.

Please see the accompanying full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.

You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Herceptin

Who is Herceptin for?

Adjuvant Breast Cancer

Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high risk feature.* Herceptin can be used in several different ways:

  • As part of a treatment course including the chemotherapy drugs Adriamycin® (doxorubicin), Cytoxan® (cyclophosphamide), and either Taxol®(paclitaxel) or Taxotere® (docetaxel). This treatment course is known as "AC-->TH"
  • With the chemotherapy drugs Taxotere and Paraplatin® (carboplatin). This treatment course is known as "TCH"
  • Alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based therapy (a type of chemotherapy)

*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. 
Adriamycin is a registered trademark of Pharmacia Inc. 
Cytoxan, Taxol, and Paraplatin are registered trademarks of Bristol-Myers Squibb Company. 
Taxotere is a registered trademark of sanofi-aventis U.S. LLC.

Metastatic Breast Cancer

Herceptin has 2 approved uses in metastatic breast cancer:

  • Herceptin in combination with the chemotherapy drug Taxol® (paclitaxel) is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
  • Herceptin alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Taxol is a registered trademark of Bristol-Myers Squibb Company.

Gastric Cancer

Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.

What possible Serious Side Effects and Additional Important Safety Information should I know about Herceptin?

  • Herceptin treatment can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). One patient died in an adjuvant (early) breast cancer trial of significantly weakened heart muscle.
  • Your doctor will evaluate your heart function before and during treatment. For adjuvant breast cancer therapy, your doctor will also evaluate heart function after the end of treatment. Your doctor will stop Herceptin therapy if you have serious weakening of the heart muscle or changes in the heart muscle structure.
  • Some patients have had serious infusion reactions and lung problems; infusion reactions leading to death have been reported. Your doctor may have you completely stop Herceptin treatment if you have a severe allergic reaction, swelling, lung problems, swelling of the lungs, or severe shortness of breath.
  • Herceptin can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman.
  • Worsening of low white blood cell counts associated with chemotherapy has also occurred.
  • You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin.
  • The most common side effects associated with Herceptin in patients with breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain.
  • The most common side effects associated with Herceptin in patients with stomach cancer are low white and red blood cell counts, diarrhea, fatigue, swelling of the mouth lining, weight loss, upper respiratory tract infections, fever, low platelet counts, swelling of the mucous membranes, swelling of the nose and throat, and a change in taste.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, you should talk to your doctor.


Please see the full Prescribing Information, for Serious Side Effects and additional important safety information. 

KADCYLA

Who is KADCYLA for?

KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) in patients who have received prior treatment with trastuzumab (Herceptin® ) and a taxane.

Important Safety Information

What is the most important safety information I should know about KADCYLA?

KADCYLA is not the same medicine as trastuzumab (Herceptin)

There are possible serious side effects of KADCYLA.

Contact your doctor right away if you experience any of these symptoms. Your doctor may do tests before starting KADCYLA and before each dose to monitor for these side effects. KADCYLA treatment may be stopped or the dose may be lowered if you experience any of these side effects.

Liver problems

  • KADCYLA may cause severe liver problems that can be life-­threatening. Symptoms of liver problems may include vomiting, nausea, stomach pain, dark urine, or itching

Heart problems

  • KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, or rapid weight gain of greater than 5 lbs in less than 24 hours

Pregnancy

  • Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while you receive KADCYLA and for 6 months after your last dose of KADCYLA
  • If you are exposed to KADCYLA during pregnancy, contact your healthcare provider right away; you are also encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720
  • If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping KADCYLA

What are the additional possible serious side effects of KADCYLA?

Lung problems

  • KADCYLA may cause lung problems, including inflammation of the lung tissue, which can be life- threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs

Infusion­-related reactions

  • Symptoms of an infusion-­related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. Your doctor will monitor you for infusion-­related reactions

Low platelet count

  • Low platelet count may happen during treatment with KADCYLA. Platelets are cells in your blood that help your blood clot

Nerve damage

  • Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, or muscle weakness or loss of muscle function

Skin reactions around the infusion site

  • KADCYLA may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion

How will my doctor know if KADCYLA is right for me?

You must have a HER2 test to determine if your cancer is HER2-positive before taking KADCYLA, as benefit has only been shown in patients whose tumors are HER2­-positive.

What are the most common side effects of KADCYLA?

The most common side effects seen in people taking KADCYLA were:

  • Tiredness
  • Nausea
  • Pain that affects the bones, muscles, ligaments, and tendons
  • Low platelet count
  • Headache
  • Liver problems
  • Constipation

The most common severe side effects of KADCYLA are:

  • Low platelet count
  • Liver problems
  • Low levels of red blood cells
  • Nerve problems
  • Low levels of potassium in the blood
  • Tiredness

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see accompanying full Prescribing Information for additional important safety information, including Boxed WARNINGS.

PERJETA

What does PERJETA treat?

PERJETA® (pertuzumab) is approved for use in combination with Herceptin® (trastuzumab) and docetaxel (chemotherapy) in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

PERJETA® (pertuzumab) is approved for use prior to surgery in combination with Herceptin® (trastuzumab) and docetaxel (chemotherapy) in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than 2 cm in diameter or node positive) breast cancer. PERJETA should be used as part of a complete treatment regimen for early stage breast cancer. This use of PERJETA is based on an improvement in the percentage of patients whose cancer shrinks or disappears after treatment. Currently, no data have shown whether or not treatment with PERJETA prior to surgery improves survival.

  • The safety of PERJETA in combination with doxorubicin-containing regimens has not been established
  • The safety of PERJETA administered following surgery has not been established

Important Safety Information

    • PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure)
    • Receiving PERJETA during pregnancy can result in the death of an unborn baby and birth defects

- If you think you may be pregnant, you should contact your healthcare provider immediately

- If you are exposed to PERJETA during pregnancy, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting
  1-800-690-6720

    • PERJETA should not be used in patients who are allergic to pertuzumab or to any of the ingredients in PERJETA
    • Other possible serious side effects of PERJETA therapy include:

- Infusion-related reactions

- Severe allergic reactions (hypersensitivity reactions/anaphylaxis)

  • PERJETA has only been shown to work in people with HER2-positive breast cancer
  • The most common side effects of PERJETA when given with Herceptin and docetaxel (chemotherapy) for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

- Diarrhea

- Hair loss

- Low levels of white blood cells with or without a fever

- Nausea

- Feeling tired

- Rash

- Damage to the nerves (numbness, tingling, pain in hands/feet)

  • The most common side effects of PERJETA when given with Herceptin and docetaxel (chemotherapy) as part of an early breast cancer regimen before surgery are:

- Hair loss

- Diarrhea

- Nausea

- Low levels of white blood cells with or without a fever

  • The most common side effects of PERJETA when given with Herceptin and docetaxel following 3 cycles of epirubicin, cyclophosphamide, and fluorouracil as part of an early breast cancer regimen before surgery are:

- Feeling tired

- Hair loss

- Diarrhea

- Nausea

- Vomiting

- Low levels of white blood cells with or without a fever

  • The most common side effects of PERJETA when given with Herceptin, docetaxel, and carboplatin as part of an early breast cancer regimen before surgery are:

- Feeling tired

- Hair loss

- Diarrhea

- Nausea

- Vomiting

- Low levels of white blood cells with or without a fever

- Low platelet count

- Low levels of red blood cells

 

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see PERJETA full Prescribing Information, including Most Serious Side Effects, for additional Important Safety Information.

PERJETA® and the Access Solutions logo are registered trademarks of Genentech, Inc.

Rituxan NHL and CLL

INDICATIONS

RITUXAN® (Rituximab) is indicated for the treatment of:

  • Low-grade or follicular CD20-positive Non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
  • Follicular CD20-positive Non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
  • Low-grade or follicular CD20-positive Non-Hodgkin’s lymphoma as a single agent follow-up therapy for patients who responded to initial treatment with CVP chemotherapy
  • CD20-positive diffuse large B-cell Non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
  • CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

People with serious infections should not receive RITUXAN.

What is the most important information I should know about Rituxan?

Tell your doctor right away about any side effect you experience. Rituxan can cause serious side effects that can lead to death, including:

  • Infusion Reactions: may occur during or within 24 hours of your infusion. Your doctor should give you medicines before your treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain
  • Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on your skin, lips or mouth; peeling skin; rash; or pustules
  • Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If you have had hepatitis B or are a carrier of HBV, receiving Rituxan could cause the virus to become an active infection again. You should not receive Rituxan if you have active HBV liver disease. Your doctor will do blood tests to check for HBV infection prior to treatment and will monitor you during and for several months following your treatment
  • Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment, or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of your body, or blurred or lost vision

What are the additional possible serious side effects of Rituxan?

Tell your doctor right away about any side effect you experience. Rituxan can cause serious side effects that can lead to death, including:

  • Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. Your doctor may give you medicines before your treatment to help prevent TLS
  • Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen, or painful
  • Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. Your doctor may need to stop your treatment
  • Kidney Problems: your doctor should do blood tests to check how well your kidneys are working
  • Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom
  • Low Blood Cell Counts: your blood cell counts may be monitored during treatment

The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells. Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if Rituxan may harm your unborn baby or pass into your breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.

Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects of Rituxan. For more information, ask your doctor or pharmacist.

Please see the Rituxan full Prescribing Information, including Most Serious Side Effects, for additional important safety information at www.Rituxan.com.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

RITUXAN® and its logo are trademarks of Biogen Idec, Inc.

The Access Solutions logo is a registered trademark of Genentech, Inc.

Tarceva

Who is Tarceva for?

Tarceva is approved as a 1st-line treatment, maintenance treatment, and 2nd- or 3rd-line treatment for advanced-stage non-small cell lung cancer (NSCLC).

  • Tarceva is prescribed as initial treatment for patients with NSCLC whose cancer has spread to other parts of the body and that has certain types of epidermal growth factor receptor (EGFR) mutations. (1st-line treatment)
  • Tarceva is prescribed as maintenance treatment for advanced-stage NSCLC in patients whose cancer has not spread or grown after prior treatment with certain types of chemotherapy.
  • Tarceva is prescribed as 2nd- or 3rd-line treatment for advanced-stage NSCLC in patients whose cancer has spread or grown after receiving at least one round of chemotherapy.
  • Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
  • For initial treatment of patients with NSCLC whose cancer has spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.

Tarceva is approved for advanced-stage pancreatic cancer.

  • Tarceva in combination with gemcitabine is prescribed for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.

Important Safety Information

What is the most important information I should know about Tarceva?

Everyone reacts differently to treatment with Tarceva. Some people may have side effects, while others may not. It’s important to know the most common and serious side effects with Tarceva.

Your healthcare provider (HCP) may lower the dose or stop treatment with Tarceva if any serious side effects occur. Contact your HCP right away if you experience any of the following side effects.

What are the possible side effects of Tarceva?

Tarceva can cause serious side effects, which include:

  • Interstitial lung disease, or ILD, events. Tarceva has been shown to cause lung problems, including death. Symptoms of lung problems may include shortness of breath, cough, and fever. Tarceva may need to be stopped if you have any of these symptoms.
  • Liver and kidney problems. Tarceva has been shown to cause severe kidney and liver problems, including death. Some people had their kidneys and liver stop working. Let your HCP know if you have a history of liver or kidney disease.
  • Gastrointestinal (GI) perforation. Tarceva has been shown to cause GI perforation, a hole that develops in your stomach or intestine, which has led to death. People taking Tarceva at the same time as medications that may help block the growth of blood vessels, steroids, non-steroidal anti-inflammatory drugs (NSAIDs), or certain chemotherapies or those who have a history of ulcers or other stomach disease may be at higher risk of perforation.
  • Serious skin conditions. Tarceva has been shown to cause blistering and skin peeling. This may result in other serious skin disorders or death.
  • Blood, bleeding, and clotting problems. Tarceva has been shown to cause certain blood problems and other bleeding and clotting problems. These have led to heart attack, stroke, and death.
  • Eye disorders. Tarceva has been shown to cause eye irritation and damage to the cornea. Tarceva may also cause unusual eyelash growth or swelling of the cornea. This swelling may irritate the eye or cause damage.
  • Bleeding events when taking warfarin with Tarceva. Tell your HCP if you are taking a blood thinner, such as warfarin, or non-steroidal anti-inflammatory drugs, known as NSAIDs. Taking Tarceva with these medications can cause death.
  • Pregnancy. Tarceva can cause harm to an unborn baby. Do not breast-feed when taking Tarceva. Women should use effective birth control during treatment and for at least 2 weeks after the last dose of Tarceva. Contact your HCP if you have become pregnant or if pregnancy is suspected, during treatment with Tarceva.

When should I call my HCP while taking Tarceva?

  • Serious or ongoing diarrhea, nausea (feeling sick to your stomach), loss of appetite, or vomiting
  • New or worsening shortness of breath or cough
  • Eye irritation
  • New or worsening rash, blistering, or peeling of the skin
  • Any changes in smoking habits

What are some of the most common side effects?

  • 1st-line NSCLC treatment: Diarrhea, weakness, rash, cough, shortness of breath, and loss of appetite
  • Maintenance/2nd- or 3rd-line NSCLC treatment: Rash and diarrhea
  • Pancreatic cancer treatment: Fatigue (feeling tired), rash, nausea, loss of appetite, and diarrhea.

What should I know about skin (including rash), hair and nail problems or diarrhea while taking Tarceva?

    • Skin (including rash):

- Your skin may look red with little bumps. It may look like acne, but is not. The rash most commonly occurs on the face, upper chest, and back, but it could spread to other parts of the body and may start peeling. It could happen or get worse if the skin is exposed to the sun. You may feel itching, tenderness, or burning.

- When taking Tarceva, you may see skin and nail darkening or dry skin, with or without cracking. This most often occurs with rash.

- While taking Tarceva, you may want to use alcohol-free lotions and sunscreens or avoid being out in the sun.

- In Tarceva clinical trials, rash was treated with steroids or antibiotics. Using acne medicines may dry your skin and make the rash worse. The treatment of rash has not been studied.

- Talk with your HCP if you notice a rash. He or she may be able to help you manage it.

  • Hair and nails: Hair and nail problems have been seen in patients taking Tarceva, such as abnormal hairiness and brittle or loose nails.
  • Diarrhea: Diarrhea can usually be treated by anti-diarrhea medicine. Your HCP can help you find the right medicine for you.

What should I do if I am taking or am prescribed other medicines or supplements while taking Tarceva?

  • It is important to tell your HCP about all of the medicines and herbal supplements you are taking.
  • DO NOT start taking any new medicines or herbal supplements before talking with your HCP.
  • DO NOT eat grapefruit or drink grapefruit juice while taking Tarceva, except under the care of your HCP.

Will smoking affect my treatment with Tarceva?

  • If you smoke, you should stop smoking before starting treatment with Tarceva.
  • If you continue to smoke, your treatment with Tarceva may need to be adjusted. Talk to your HCP.

Call your HCP for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional important safety information, please see full prescribing information.

Tarceva® and its logo are trademarks of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.

The Access Solutions logo is a registered trademark of Genentech, Inc.

XELODA

Who is XELODA for?

XELODA is used to treat:

  • Cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body. This is called metastatic colorectal cancer (mCRC). XELODA is used as a single medicine to treat mCRC. In medical studies, people lived longer when they took other cancer medicines at the same time that they took 5-fluorouracil (5-FU) and leucovorin. In medical studies, XELODA used as a single medicine was no worse than 5-FU and leucovorin taken together. XELODA did not improve survival compared with these 2 medicines.
  • Cancer of the colon after surgery.
  • Breast cancer that has spread to other parts of the body. This is called metastatic breast cancer (mBC). For this kind of breast cancer, XELODA is taken together with another medicine called docetaxel.
  • Breast cancer that has spread to other parts of the body and has not improved after treatment with other medicines. These medicines include paclitaxel and anthracycline-containing medicine such as doxorubicin.

What is the most important safety information I should know about XELODA?

It is very important that your doctor knows if you are taking a medicine used to thin your blood, such as warfarin (COUMADIN®). XELODA may increase the effect of this medicine. This could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots. He or she will change the dose of the blood thinner,
if needed.

Who should not take XELODA?

Do not take XELODA if:

  • You are nursing a baby. XELODA may pass through your breast milk and to the baby and harm the baby
  • You are allergic to the chemotherapy medicines 5-FU and capecitabine or to any of the ingredients in XELODA
  • Your body doesn’t have enough of the enzyme DPD (dihydropyrimidine dehydrogenase)

What should I tell my doctor before taking XELODA?

Tell your doctor if you:

  • Are pregnant or think you may be pregnant. XELODA may harm your unborn child. Men and women should use effective birth control while taking XELODA
  • Take a blood thinner, such as warfarin
  • Take phenytoin (DILANTIN®)
  • Have kidney, liver, or heart problems
  • Take folic acid, a B complex vitamin, or a multivitamin containing folic acid

Stop taking XELODA immediately and contact your doctor right away if you have any of these serious common side effects or any other side effects that worry you:

  • Diarrhea1at least 4 more bowel movements each day than is normal for you or if you wake up because you need to have a bowel movement
  • Throwing up (vomiting)*more than once in 24 hours
  • Feeling sick to your stomach (nausea)*if you don’t feel like eating and if the amount of food you eat each day is much less than usual
  • Pain, redness, swelling, or sores in your mouth (stomatitis)*
  • Hand-and-foot syndrome—pain, swelling, or redness of your hands or feet that prevents normal activity
  • Fever or infection—a temperature of 100.5°F or higher or other signs of infection

If you do have any of the side effects listed above, or if you have other side effects that worry you, your doctor can change your dose of XELODA or stop your XELODA treatment for a while. This may help to reduce the side effects and stop them from getting worse.

What are the other common side effects of XELODA?

  • Constipation*
  • Loss of appetite*
  • Stomach area pain* or upset stomach
  • Too much water loss from the body (dehydration)*
  • Rash or dry, itchy, discolored skin
  • Nail problems
  • Hair loss
  • Tiredness or weakness
  • Dizziness or headache
  • Pain, including chest, back, joint, or muscle pain
  • Trouble sleeping
  • Problems with your sense of taste

You may have different side effects if you take XELODA with docetaxel. Please talk with your doctor about possible side effects that may be caused by taking XELODA with other medicines.

1This side effect is more common in patients 80 years and older.

Please be sure to talk with your doctor if you have any questions about your cancer or treatment.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying complete Prescribing Information.

Coumadin is a registered trademark of Bristol-Myers Squibb Company. Dilantin is a registered trademark of Pfizer Inc.

ZELBORAF

What is ZELBORAF?

ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene.

Your healthcare provider will perform a test to make sure that ZELBORAF is right for you. ZELBORAF is not used to treat melanoma with a normal BRAF gene.

Important Safety Information

ZELBORAF can cause serious side effects, including risk of cancers. ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your doctor about skin changes including a new wart, a sore or bump that bleeds or does not heal, or a mole that changes size or color.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that you get while taking ZELBORAF.

While taking ZELBORAF, you should avoid sunlight. When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs. Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

Possible serious side effects of ZELBORAF include severe allergic reactions, severe skin reactions, potentially life-threatening changes in the electrical activity of your heart called QT prolongation, abnormal liver function tests, and eye problems. Tell your doctor if you are pregnant, or plan to become pregnant, as ZELBORAF can harm your unborn baby.

Common side effects of ZELBORAF include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, or warts.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ZELBORAF. For more information about side effects, ask your doctor or pharmacist.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information and Medication Guide for additional important safety information.