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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.

 

 

 

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Indications and Important Safety Information

 

Avastin

What Does Avastin Treat?

Avastin is approved for:

  • Metastatic colorectal cancer (mCRC) for first- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy. It is also approved to treat mCRC for 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.
  • Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease
  • Metastatic kidney cancer (mRCC) when used with interferon alfa
  • Glioblastoma (GBM) when taken alone in adult patients whose cancer has progressed after prior treatment. The effectiveness of Avastin in GBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people previously treated for GBM

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 you have symptoms related to these side effects.

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

  • Gastrointestinal (GI) perforation. A hole that develops in your stomach or intestine. Symptoms include pain in the 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, do not take Avastin

Other possible serious side effects:

  • Abnormal passage in the body. This forms from one part of the body to another and can sometimes be fatal
  • Stroke or heart problems. These include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
  • 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
  • Nervous system and vision problems. Symptoms include high blood pressure, headache, seizure, sluggishness, confusion, and blindness
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion reactions. These may include difficulty breathing, chest pain, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
  • Fertility issues for women. Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children

Additional Safety Information

The most common side effects of Avastin are:

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

Avastin is not right for everyone. Talk to your doctor if you:

  • Are pregnant, may be pregnant, or are breast-feeding. Avastin may harm the fetus or a child that is nursing. If you stop Avastin, you should keep using birth control for at least 6 months after your last dose before trying to become pregnant
  • Are undergoing surgery. Don’t take Avastin for at least 28 days before or after surgery and until surgical wounds are fully healed

If you have any questions about your condition or treatment, 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 full Product Information, including Serious Side Effects, for additional important safety information.

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.

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 with 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.

Important Safety Information

  • Most Serious Side Effect: 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

  • Other possible serious side effects of PERJETA therapy include:

- Heart problems

- Infusion-related reactions

- Severe allergic reactions (hypersensitivity reactions/anaphylaxis)

  • PERJETA has been shown to work only in people with HER2-positive breast cancer
  • The most common side effects of PERJETA when given with Herceptin and docetaxel (chemotherapy) 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)

You are encouraged to report side effects to Genentech or the FDA. 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 PERJETA full Prescribing Information including Most Serious Side Effect for additional Important Safety Information.

Rituxan NHL and CLL

INDICATIONS

RITUXAN® (rituximab) is indicated for the treatment of patients with:

  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as single-agent maintenance therapy
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent

RITUXAN is indicated in combination with fludarabine and cyclophosphamide (FC chemotherapy) for the treatment of patients with:

  • Previously untreated CD20-positive CLL
  • Previously treated CD20-positive CLL

People with serious infections should not receive RITUXAN.

 

IMPORTANT SAFETY INFORMATION

  • RITUXAN can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).
  • RITUXAN has also been associated with serious and life-threatening side effects, including: the return of active hepatitis B virus infection with sudden and serious liver problems including liver failure, and death, other serious infections that can lead to death, heart problems, kidney problems, and stomach and serious bowel problems including blockage and tears in the bowel that can sometimes lead to death.
  • The most common side effects of RITUXAN seen in patients with non-Hodgkin’s lymphoma were infusion reactions, fever, chills, low white blood cells, infections, body aches, and tiredness. Before starting treatment with RITUXAN it is important to talk to your doctor about your medical history
  • The most common side effects of RITUXAN seen in clinical trials of patients with CLL were infusion reactions and low white blood cells, which can increase the risk of infections. Before starting treatment with RITUXAN it is important for you to talk to your doctor about your medical history
  • 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 with RITUXAN. For more information, ask 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 full Prescribing Information, including Medication Guide.

Tarceva

What does Tarceva Treat?

Tarceva is approved for:
Maintenance Therapy and Second- or Third-Line Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC):

  • Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy. (Maintenance treatment)
  • Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen. (2nd/3rd-line treatment)
  • Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.

Advanced 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

Possible Side Effects
Everyone reacts differently to Tarceva 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 healthcare team if you have symptoms related to these side effects.

  • Interstitial lung disease (ILD)-like events. Problems occurring in the lungs (including deaths). Tarceva may need to be stopped if new or unexplained serious symptoms of shortness of breath, cough, and fever occur.
  • Liver and/or kidney problems. Some events have included death. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.
  • Gastrointestinal (GI) perforation. A hole that develops in your stomach or intestine. Some events have included death.
  • Serious skin conditions. Some events have included death.
  • Bleeding and clotting problems. Heart attack or stroke in patients receiving Tarceva plus gemcitabine for advanced pancreatic cancer.
  • Eye disorders. Eye irritation and damage to the cornea.
  • Bleeding events when taking warfarin. Some events have included death. Tell your doctor if you are taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs).
  • Pregnancy problems. You should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

Additional Safety Information
Call your HCP right away if you have these signs or symptoms:

  • New or worsening skin rash
  • Serious or ongoing diarrhea, nausea, loss of appetite, or vomiting
  • New or worsening shortness of breath or cough
  • Eye irritation

The most common side effects when receiving Tarceva alone for advanced NSCLC are generally mild to moderate rash and diarrhea.

The most common side effects when receiving Tarceva plus gemcitabine for advanced pancreatic cancer are fatigue (feeling tired), rash, nausea, loss of appetite and diarrhea.

Additional Important Information
It is important that you 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 on treatment with Tarceva, except under the care of your HCP.

Smoking may affect how well Tarceva works for you.

  • If you smoke, you should stop smoking before starting treatment with Tarceva.
  • If you continue to smoke, you should talk to your HCP before taking Tarceva.

Always let your HCP know if you have any side effects, and ask about the best way to handle them.

Tarceva is not right for everyone. Ask your HCP if once-daily Tarceva is right for you.

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.

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:

  • Diarrhea1—at 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

Indication and Important Safety Information

This information does not take the place of talking to your doctor about your medical condition or your treatment with 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.

ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).  CuSCC usually does not spread to other parts of the body.  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.

While taking ZELBORAF, you should avoid going out in the sun.  When you go outside, wear clothes that protect your skin, including 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, changes in the electrical activity of your heart called QT prolongation, which can potentially be life-threatening, abnormal liver function tests, eye problems, or new melanoma lesions.

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

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

Call your doctor for medical advice about any 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.

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