Important Safety Information
Serious side effects and risks associated with the treatment with CAMZYOS are:
- Heart failure due to systolic dysfunction, a condition where the heart cannot pump enough blood to the body
- Heart failure due to interactions with certain medicines and herbal supplements
- Embryo-fetal toxicity (toxicity to an unborn baby)
Other possible side effects related to CAMZYOS are outlined in the Patient Medication Information.
CAMZYOS and heart failure
Heart failure due to systolic dysfunction is a serious and sometimes fatal condition.
Tell your prescriber or doctor; or seek other medical attention immediately if you experience new or worsening symptoms of heart failure, including shortness of breath, chest pain, fatigue, rapid weight gain, a racing heart (palpitations) or leg swelling.
Tell your prescriber or doctor of any new or existing medical condition(s) you experience before and during treatment with CAMZYOS. Certain conditions, such as infections or atrial fibrillation (irregular and rapid heartbeat), may impact your treatment with CAMZYOS.
CAMZYOS and drug interactions
Some products, including prescription or over-the-counter medicines, vitamins, some herbal supplements and grapefruit juice can affect the levels of CAMZYOS in your body and may increase the risk of heart failure due to systolic dysfunction.
Talk about any health conditions or problems you may have, including if you are taking any prescription, over-the-counter medicines, vitamins, herbal supplements or grapefruit juice, even if you do not take them every day. Do not start taking, stop taking or change the dose of any of your medicines or herbal supplements without talking to your prescriber, doctor or pharmacist.
Some examples of medicines and products that may affect how much CAMZYOS is in your body are shown in Table 1. Please note, these examples are a guide and are not considered a comprehensive list of all possible medicines that may fit this category. Intermittent use of products that might affect the levels of CAMZYOS in your body, including prescription and over-the-counter medicines, vitamins, herbal supplements and grapefruit juice, is not recommended.
| Medicines/products | Condition treated |
|---|---|
| Omeprazole, esomeprazole | Gastric ulcers and acid reflux |
| Clarithromycin, rifampicin | Bacterial infections |
| Verapamil, diltiazem | Heart conditions |
| Fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole | Fungal infections |
| Fluoxetine, fluvoxamine | Depression |
| Ritonavir, cobicistat | Human immunodeficiency virus (HIV) |
| Telaprevir | Hepatitis C |
| Grapefruit juice |
CAMZYOS and embryo-fetal toxicity (toxicity to unborn baby)
CAMZYOS must not be taken if you are pregnant or if you are of childbearing potential and are not using a highly effective method of contraception (birth control) as CAMZYOS may cause harm to an unborn baby.
If you are able to get pregnant, you will need a confirmed negative pregnancy test before you start taking CAMZYOS. You must use a highly effective method of contraception throughout treatment and for at least 4 months after your last dose of CAMZYOS. You should discuss with your doctor which method(s) of contraception is/are the most suitable for you.
Talk to your doctor if you are considering becoming pregnant. If you suspect you may become pregnant or are pregnant while receiving CAMZYOS, tell your prescriber or doctor immediately. Your prescriber or doctor will discuss your treatment options with you.