Identifying Potential Side Effects
As you begin treatment with LORBRENA®, it may be helpful to learn more about what to expect. To help you identify potential side effects, the serious and most common have been outlined below. Be sure to share with your doctor if you experience these or any other side effects. It's important to remember that everyone responds to treatment differently, so you may or may not experience some of the side effects described here.
Serious Side Effects
LORBRENA may cause serious side effects, 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 experience 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. If these problems are severe, 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 their 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. If these problems are severe, 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.
- Risks related to pregnancy. If you 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. 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.
If these problems are severe, your healthcare provider may need to have you stop taking LORBRENA.
Common Side Effects
The most common side effects of LORBRENA include:
- 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
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.
These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
LORBRENA may cause some side effects that you did not experience while on other ALK inhibitor medicines. These side effects include increased cholesterol and/or triglycerides, hallucinations, seizures, and changes in mood, memory, thinking, or speech.
If you experience side effects, know that with your doctor's guidance, there may be ways to help manage them.
It may be helpful to have an open conversation with your family or caregiver about the potential side effects of LORBRENA. They may be able to help you recognize any changes and can help you share them with your doctor.