Rozlytrek

Though rare, some people developed heart failure, typically within 2 months after starting Rozlytrek (entrectinib). Your provider will do an ultrasound of your heart before starting treatment, and they’ll also check you for heart failure symptoms regularly throughout treatment. If you develop heart failure, your provider might have you take a break from Rozlytrek (entrectinib). They also might recommend medications to help your heart pump better and have you restart Rozlytrek (entrectinib) at a lower dose. Let your provider know if you have symptoms of heart failure, such as trouble breathing (especially when lying down), coughing or wheezing, or swelling in the legs.

In studies, people treated with Rozlytrek (entrectinib) experienced a variety of side effects in the central nervous system, including confusion, mood changes, dizziness, and changes in sleeping patterns. The majority of people noticed these side effects within 1-3 months of starting the medication (sometimes, as early as a day after starting treatment). If you have these side effects, avoid driving or doing anything that needs concentration until you’ve been checked out by a healthcare provider. They might have you take a break from Rozlytrek (entrectinib) to allow time for you to recover. Let your healthcare team know if you have any new or worsening dizziness, mood changes, hallucinations, sleep disturbances, or problems with memory and concentration.

Taking Rozlytrek (entrectinib) can put people at higher risk for broken bones (fractures), most commonly in the hip or leg. The risk is higher for children. About half of people who had fractures while taking Rozlytrek (entrectinib) experienced the fracture within 4 months after starting the medication. If you fall down, have new muscle or bone pain, or are having more trouble moving around than usual, contact your provider. They can do scans to check for fractures and recommend strategies to manage pain.

Rozlytrek (entrectinib) can cause eye problems, including blurry vision, sensitivity to light, and double vision. If you notice changes in your eyesight, let your provider know. They might have you temporarily stop taking Rozlytrek (entrectinib) and refer you to an eye specialist. Once your symptoms have lessened or stopped getting worse, your provider might have you restart Rozlytrek (entrectinib) at a lower dose, depending on your symptoms.

Let your provider know if you are pregnant or plan to become pregnant. Rozlytrek (entrectinib) hasn’t been studied in human pregnancy , but it’s likely to cause harm to the unborn baby based on animal studies. If you’re able to become pregnant, your provider will have you do a pregnancy test before starting treatment. They’ll also ask you to use effective birth control while taking this medication and for at least 5 weeks after your last dose. If you’re male and have a partner who’s able to become pregnant, continue using effective birth control while taking Rozlytrek (entrectinib) and for at least 4 months after your last dose.

In studies, signs of liver injury on lab tests were a common, mild side effect of Rozlytrek (entrectinib) that typically appeared within the first few weeks of treatment. But in rare situations, these lab tests indicated serious liver injury. Your provider will do blood tests before starting treatment, every 2 weeks for the first month, and then monthly afterward to check your liver. If you notice signs of liver injury, such as pain in the upper right side of the stomach, yellowing of the eyes or skin, or dark or brown urine, let your healthcare team know. They’ll have you take a break from Rozlytrek (entrectinib) and potentially adjust the dose once your liver labs return to normal.