• Alecensa is a brand (trade) name for alectinib hydrochloride which is a medicine that may be used to treat a certain type of advanced non-small cell lung cancer (NSCLC).
• Alecensa (alectinib) works by targeting anaplastic lymphoma kinase (ALK). ALK belongs to a family of proteins called receptor tyrosine kinases which are involved in the growth of cells and the development of new blood vessels that supply them. People with ALK-positive NSCLC have an abnormal form of ALK that stimulates the cancer cells to divide and grow in an uncontrolled fashion. ALK is involved in the growth of several human cancers such as anaplastic large-cell lymphoma, lung cancer, inflammatory myofibroblastic tumors, and neuroblastoma. Alecensa inhibits ALK phosphorylation and ALK-mediated activation of two signaling proteins (STAT3 and AKT), which helps slow the growth and spread of cancer. Alecensa is metabolized to an active metabolite, M4, which has similar potency and activity and both Alecensa and M4 are effective against multiple mutant forms of the ALK enzyme.
• The ALK gene mutation is detected by an FDA-approved test. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history. Approximately 5 percent of people with NSCLC in the United States are ALK-positive.
• Alecensa belongs to the class of medicines called multikinase inhibitors. It may also be called a tyrosine kinase inhibitor.

• May be used to treat advanced non-small cell lung cancer (NSCLC) that is caused by a mutation in the anaplastic lymphoma kinase (ALK) gene.
• Alecensa is a capsule that is taken by mouth (orally). The usual dosage is 600mg twice a day.
• Effective at treating ALK-positive NSCLC in at least three studies.
• Alecensa is usually given on its own.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Constipation, fatigue, muscle pain, nausea, diarrhea, edema, rash, a slow heartbeat, vision disorders, kidney impairment, vomiting, and taste disturbances are the most common side effects reported. Weight gain, photosensitivity reactions, mouth ulcers, and lung and liver disease may also occur.
• Alecensa is associated with several laboratory abnormalities, including elevations in liver enzymes; low calcium, sodium, potassium, glucose, albumin, and phosphate levels; anemia, lymphopenia, and neutropenia. perform regular monitoring.
• Alecensa may need to be temporarily or permanently discontinued or the dosage reduced if certain side effects occur. Follow the guidelines in the product information (PI).
• Elevations in liver enzymes greater than 5 times the upper limit of normal (ULN) have occurred with Alecensa in 4.6% of patients (AST) and 5.3% of patients (ALT). Elevations of bilirubin of 3 times the ULN occurred in 3.7% of patients. The majority of these occurred during the first 3 months of treatment. Liver function tests should be monitored every two weeks during the first 3 months of treatment, then once a month thereafter or as clinically indicated. Follow the PI for appropriate management. The dosage of Alecensa needs to be reduced in severe liver disease (Child-Pugh C) to 450mg twice daily.
• Interstitial Lung Disease (ILD)/pneumonitis can occur with Alecensa treatment, although it is rare (0.7% of patients). Monitor patients for respiratory symptoms such as shortness of breath (dyspnea), cough, or fever. In patients diagnosed with ILD/pneumonitis immediately withhold Alecensa and permanently discontinue if no other potential causes of ILD/pneumonitis have been found.
• Alecensa can adversely affect the kidneys. Renal impairment occurred in 8% of patients; 1.7% were classed as Grade ≥ 3 and 0.5% of these were fatal events. 3.2% of patients with renal impairment required their dosage to be reduced. Dose modifications for renal impairment were required in 3.2% of patients and renal function should be monitored periodically.
• Alecensa can slow the heartbeat. In one trial, 18% of participants with serial ECGs had heart rates of less than 50 beats per minute. Heart rate and blood pressure should be monitored regularly and the PI followed for appropriate management.
• 26% of patients experienced muscle aches and pain while taking Alecensa; 0.7% reported it as being severe. Elevations in CPK occurred in 41% and 4% were Grade 3 with a median time to elevation of 14 days. Assess CPK levels every 2 weeks for the first month of treatment and then as indicated in patients reporting symptoms.
• Only approved for use in people with advanced (metastatic) NSCLC that have tested positive for the ALK gene mutation using an FDA-approved test.
• Alecensa may harm a developing fetus. Advise women of childbearing potential to use effective contraception during Alecensa treatment and for one week following the final dose. There is also no data about the effects of Alecensa on a newborn when breastfeeding. Advise women not to breastfeed during treatment with Alecensa and for at least one week after the last dose. No effects on fertility have been reported.
• A generic form of Alecensa is not currently available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Alecensa should be taken with food. The capsule should be swallowed whole; do not open the capsule or try to dissolve the capsule.
• If you miss a dose of Alecensa, or vomit soon after taking a dose, do not take another dose. Just take the next dose at the scheduled time.
• Alecensa has been associated with some serious side effects, such as severe muscle pain, pneumonitis, a slow heartbeat, and kidney and liver disease. Report any side effects, such as shortness of breath, cough, fever, abdominal pain, skin yellowing, bleeding or bruising, urinary problems (such as a change in color or output), edema, slow heart rate, unexplained muscle pain, tenderness, or weakness to your doctor as soon as possible.
• See your doctor regularly for routine monitoring of your blood pressure, liver function, blood counts, and other vital signs.
• Tell all healthcare professionals that you are taking Alecensa. Some medications, including those brought over the counter from a drug store or gas station, can interact with Alecensa.
• Avoid prolonged sun exposure while taking Alecensa and for at least 7 days after you have stopped taking it. Whenever outside, use a broad-spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm (SPF ≥ 50) to help protect against potential sunburn.
• Your healthcare provider should do a pregnancy test before you start treatment with Alecensa. Use effective contraception while receiving Alecensa and for one week after the last dose. If you inadvertently become pregnant, see your doctor immediately. Males with female partners who can become pregnant should use effective birth control (contraception) during treatment and for three months after their last dose of Alecensa. You should also not breastfeed while taking Alecensa and for at least one week after the last dose.

• Alecensa is administered until disease progression or unacceptable toxicity occurs.
• In previously untreated ALK-positive metastatic NSCLC, the overall response rate (ORR) to Alecensa was 79% in 152 patients administered Alecensa compared to an ORR of 72% in 151 patients administered crizotinib. 13% had a complete response to Alecensa and 66% had a partial response. The response persisted for >/= 6 months in 82%, >/= 12 months in 64%, and >/=18 months in 37%.

Medicines that interact with Alecensa may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Alecensa. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Alecensa include:

• aminolevulinic acid
• anthracyclines such as epirubicin
• antimetabolites, such as clofarabine
• beta-blockers such as acebutolol, atenolol, or betaxolol
• cannabidiol
• cholinesterase inhibitors such as donepezil
• digoxin
• fingolimod
• heart medications such as flecainide or verapamil
• herbals, such as black cohosh
• HIV medications, such as atazanavir or efavirenz
• interferon beta-1a and -1b and peginterferon beta-1a
• leflunomide
• lomitapide
• mefloquine
• methotrexate
• naltrexone
• other kinase inhibitors, such as brigatinib
• quinine
• siponimod
• thalidomide
• tuberculosis medications, such as bedaquinine.

Laboratory studies have shown that Alecensa and its metabolite do not inhibit hepatic enzymes CYP1A2, 2B6, 2C9, 2C19, or 2D6.

Note that this list is not all-inclusive and includes only common medications that may interact with Alecensa. You should refer to the prescribing information for Alecensa for a complete list of interactions.