Alunbrig

Alunbrig is a prescription medication used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body in people who have already been treated with crizotinib (Xalkori) and have not improved or worsened. Alunbrig belongs to a class of medications called kinase inhibitors. These work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

This medication comes in a tablet form and is usually taken with or without food once daily.

Common side effects of Alunbrig include nausea, diarrhea, fatigue, cough, and headache.

Alunbrig is a prescription medication used to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) that has spread to other parts of the body in people who have already been treated with crizotinib (Xalkori) and have not improved or worsened.  

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Serious side effects have been reported with Alunbrig. See the “Alunbrig Precautions” section.

Common side effects of Alunbrig include the following:

• nausea
• diarrhea
• vomiting
• tiredness
• cough
• headache

This is not a complete list of Alunbrig side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone. These drugs may increase the concentration of Alunbrig and cause toxicities.
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort. These drugs may decrease concentration and effectiveness of Alunbrig.
• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor). Alunbrig may alter concentration and effectiveness of these drugs.

This is not a complete list of  Alunbrig drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Alunbrig including the following:

• Lung problems. Alunbrig may cause severe swelling (inflammation) of the lungs any time during treatment, and can lead to death. These lung problems happen especially within the first week of treatment with Alunbrig. Symptoms may be similar to lung cancer symptoms. Tell your healthcare provider right away if you have any new or worsening symptoms, including:
  • trouble breathing or shortness of breath
  • chest pain
  • cough with or without mucous
  • fever
• High blood pressure. Alunbrig may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with Alunbrig. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
• Slow heart rate. Alunbrig may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with Alunbrig.
• Vision problems. Alunbrig may cause vision problems. Your healthcare provider may stop Alunbrig and refer you to an eye specialist if you develop severe vision problems during treatment with Alunbrig. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • double vision
  • seeing flashes of light
  • blurry vision
  • light hurting your eyes
• Muscle pain, tenderness, and weakness. Alunbrig may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with Alunbrig. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain, tenderness, or weakness.
• Inflammation of the pancreas. Alunbrig may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with Alunbrig. Tell your healthcare provider right away if you have some or all of the following symptoms of pancreatitis:
  • abdominal pain that may spread to the back and get worse with eating
  • weight loss
  • nausea
• High blood sugar. Alunbrig may raise your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with Alunbrig. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you have some or all of the following symptoms of high blood sugar:
  • feeling very thirsty
  • needing to urinate more than usual
  • feeling weak or tired
  • feeling very hungry
• Harm to your unborn baby. Don't take Alunbrig if you are pregnant or plan to get pregnant. 
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with Alunbrig and for at least 4 months after the last dose of Alunbrig.
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with Alunbrig and for at least 3 months after the last dose of Alunbrig.

Do not take Alunbrig if you are allergic to Alunbrig or to any of its ingredients

Grapefruit and grapefruit juice may interact with Alunbrig and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Alunbrig or to any of its ingredients
• have or have ever had high blood pressure
• have or have ever had a slow heartbeat
• have or have ever had diabetes or other blood sugar problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

There are no well-controlled studies that have been done in pregnant women. Based on how Alunbrig works, it may harm your unborn baby. Alunbrig should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Alunbrig crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of Alunbrig.

Take Alunbrig exactly as prescribed.

Alunbrig comes in a tablet form and is usually taken with or without food, once daily.

Swallow Alunbrig tablets whole. Do not crush or chew tablets.

If you miss a dose of Alunbrig, do not take the missed dose. Take your next dose at your regular time.

If you vomit after taking a dose of Alunbrig, do not take an extra dose. Take your next dose at your regular time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The usual initial dose of Alunbrig is 90 mg for the first 7 days of treatment. If you tolerate this dose of Alunbrig well, your healthcare provider may increase your dose after the first 7 days of treatment.

If you take too much Alunbrig, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Alunbrig at room temperature 20°C to 25°C (68°F to 77°F).

Keep Alunbrig and all medicines out of the reach of children.