FDA approves Alecensa
The U.S. Food and Drug Administration has approved Alecensa (alectinib), an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Important information
Alecensa may cause serious side effects, including:
Liver problems (hepatotoxicity)
Alecensa may cause liver injury. Your healthcare provider will do blood tests at least every two weeks for the first two months and as needed during treatment. Tell your healthcare provider right away if you get any of the following signs and symptoms:
feeling tired
feeling less hungry than usual
yellowing of your skin or the whites of your eyes
dark urine
itchy skin
nausea or vomiting
pain on the right side of your stomach area
bleeding or bruising more easily than normal
Lung problems
Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.
Slow heartbeat (bradycardia) Alecensa may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate and blood pressure during treatment. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment. Tell your healthcare provider if you take any heart or blood pressure medicines.
Muscle pain, tenderness, and weakness (myalgia)
Muscle problems are common with Alecensa and can be severe. Your healthcare provider will do blood tests at least every two weeks for the first month and as needed during treatment. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
Alecensa is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and has spread to other parts of your body, and who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib.
It is not known if Alecensa is safe and effective in children.
Before you take Alecensa, tell your healthcare provider about all of your medical conditions, including if you:
have liver problems
have lung or breathing problems
have a slow heartbeat
are pregnant or plan to become pregnant. Alecensa can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment, or think you may be pregnant.
Females who are able to become pregnant should use effective birth control during treatment, and for one week after the final dose.
Males who have female partners that are able to become pregnant should use effective birth control during treatment, and for three months after the final dose.
are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into your breast milk. Do not breastfeed during treatment, and for one week after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.
Take Alecensa exactly as your healthcare provider tells you to take it. Do not change your dose or stop treatment unless your healthcare provider tells you to.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you have side effects.
Take Alecensa two times a day with food.
Swallow the capsules whole. Do not open or dissolve the capsule contents.
If you miss a dose, do not take the missed dose. Take your next dose at your regular time.
If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.
Avoid spending time in the sunlight during treatment, and for seven days after the final dose. You may burn more easily and get severe sunburns. Use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.
Alecensa side effects
Alecensa may cause serious side effects, including:
See Important information about Alecensa
The most common side effects include:
tiredness
constipation
swelling in your hands, feet, ankles, and eyelids
These are not all of the possible side effects.
For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
Source: drugs.com
