Lorbrena

Lorbrena is a prescription medication used to treat certain people with metastatic non-small cell lung cancer (NSCLC) that has progressed on other anticancer medications.

Lorbrena belongs to a group of drugs called anaplastic lymphoma kinase (ALK) inhibitors. These help stop the growth of cancer by binding to specific enzymes in the cancer cells and stopping the enzyme’s activity.

This medication comes in tablet form and is taken once daily, with or without food. Do not chew, divide, or break Lorbrena tablets. Swallow tablets whole.

Common side effects include swelling, numbness and tingling feeling in your joints or arms and legs, and breathing difficulty. Lorbrena can also cause extreme tiredness (fatigue) and dizziness. Do not drive or operate heavy machinery until you know how Lorbrena affects you.

Lorbrena is a prescription medication used to treat people with non-small cell lung cancer (NSCLC):

• that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene and,
• that has spread to other parts of your body and,
• who have taken the medicine alectinib or ceritinib or who have taken both the medicine crizotinib and at least 1 other medicine to treat NSCLC that is caused by the ALK gene, and
• their NSCLC is no longer responding to these treatments.

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

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

Common side effects of Lorbrena include the following:

• swelling in your arms, legs, hands and feet (edema)
• numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
• difficulty thinking or confusion
• difficulty breathing
• tiredness (fatigue)
• weight gain
• pain in your joints
• changes in mood, feeling sad or anxious
• diarrhea

Lorbrena can also cause extreme tiredness (fatigue) and dizziness. Do not drive or operate heavy machinery until you know how Lorbrena affects you.

Lorbrena may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

This is not a complete list of Lorbrena 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 (CYP3A) 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

• Medications that increase the activity of the enzyme CYP3A such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

• Medications that use the enzyme CYP3A 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)  

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

Serious side effects have been reported with Lorbrena including:

• Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with Lorbrena.
• Problems with brain (central nervous system [CNS]) function. Many patients experienced problems with brain function including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), and seizures during treatment with Lorbrena. In some patients, these problems are severe and your healthcare provider may need to have you stop taking Lorbrena.
• Increases in the cholesterol and triglycerides (lipid) levels in your blood. Most patients will have an increase in the lipid levels in your blood during treatment with Lorbrena.
  • If you have increases in the lipid levels in your blood during treatment with Lorbrena, your healthcare provider may need to start you on a medicine to lower the levels. If you are already taking a medicine to lower the lipid levels in your blood, your healthcare provider may need to increase your dose of that medicine.
  • Your healthcare provider should do blood tests to check the lipid levels in your blood before starting treatment, 1 to 2 months after starting treatment, and during treatment with Lorbrena.
• Heart problems. Lorbrena may cause very slow or abnormal heartbeats. Your healthcare provider should check your heart rhythm (electrocardiogram [EKG]) before starting and during treatment with Lorbrena. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. In some patients, these problems are severe and your healthcare provider may need to have you stop taking Lorbrena or have a pacemaker placed.
• Lung problems. Lorbrena may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms of lung problems, including trouble breathing, shortness of breath, cough, or fever

Do not take Lorbrena if you:

• Are allergic to Lorbrena or to any of its ingredients

• Are taking CYP3A enzyme activating drugs. See “Lorbrena Drug Interactions” for examples.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Lorbrena, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are taking other medications
• have had episodes of depression or seizures
• have high levels of cholesterol or triglycerides in your blood
• have problems with your heart beat
• have lung or breathing problems
• are pregnant or plan to become pregnant. Lorbrena can harm your unborn baby.
  • Your healthcare provider will do a pregnancy test before you start treatment with Lorbrena.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lorbrena.

• are breastfeeding or plan to breastfeed. It is not known if Lorbrena passes into your breast milk. Do not breastfeed during treatment with Lorbrena and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

–Females who are able to become pregnant should use effective non-hormonal birth control during treatment with Lorbrena and for at least 6 months after the final dose of Lorbrena. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used during treatment with Lorbrena. Talk to your healthcare provider about birth control choices that are right for you during this time.

–Males who have female partners who are able to become pregnant should use effective birth control during treatment with Lorbrena and for at least 3 months after the final dose of Lorbrena.

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.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may cause harm to your unborn baby and result in some babies to be born with problems. Talk to your doctor about the risks to your baby by using Lorbrena.

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

It is not known if Lorbrena 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, Lorbrena should not be used in women breastfeeding. Do not breastfeed for 7 days after last dose of Lorbrena. Your doctor and you will decide if the benefits outweigh the risk of using Lorbrena.

• Take Lorbrena exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Lorbrena unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Lorbrena if you develop side effects.
• Swallow Lorbrena tablets whole. Do not chew, crush, or split Lorbrena tablets. Do not take Lorbrena tablets if they are broken, cracked, or not intact.
• Take Lorbrena at approximately the same time each day.
• You may take Lorbrena with or without food.
• If you miss a dose, take it as soon as you remember. However, if it is close to the time of your next dose (within 4 hours), just take your next dose at your regular time.
• If you vomit after taking a dose of Lorbrena, 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
• Side effects your experience with Lorbrena

The recommended dose of Lorbrena (lorlatinib) for the treatment of certain metastatic non-small cell lung cancer (NSCLC) that have progressed on certain anticancer medications is 100 mg daily. Dose may be lowered to 75 mg or 50 mg daily depending on the side effects experienced.  

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

• Store Lorbrena at room temperature between 68°F to 77°F (20°C to 25°C).

• Keep this and all medicines out of the reach of children.