ALECENSA Distribution
Authorized Specialty Distributors and Specialty Pharmacies
Genentech BioOncology® Access Solutions for ALECENSA works with specialty pharmacies (SPs) to help patients receive their medicines.
An SP may provide the following services:
- Reimbursement resources
- Clinical services to support patients throughout their treatment
- The ability to manage the specialty handling and shipping needs linked with many specialty therapies
You can work with your preferred SP or contact Genentech BioOncology
Access Solutions to learn which SP the patient’s health insurance plan
requires.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Physician Offices and Federally Qualified Health Centers (Buy and Bill)
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
Important Safety Information & Indication
Indication
ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (mNSCLC) as detected by an FDA- approved test.
Important Safety Information
Hepatotoxicity: Monitor liver function tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.
Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis occurred in 0.7% of patients. Immediately withhold ALECENSA in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.
Renal Impairment: Renal impairment occurred in 8% of patients. Incidence of Grade ≥3 was 1.7%, of which 0.5% were fatal events. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.
Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then dose reduce or permanently discontinue.
Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold, then resume or dose reduce ALECENSA.
Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose.
Most Common Adverse Reactions: The most common adverse reactions (incidence ≥20%) were constipation (34%), fatigue (26%), myalgia (23%), edema (22%), and anemia (20%).
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 additional Important Safety Information in full Prescribing Information.