Important Safety Information

There are three main risks associated with treatment with CAMZYOS:

• 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-foetal toxicity (toxicity to an unborn baby).

Other possible side effects related to CAMZYOS are outlined in the patient information leaflet.

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, 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 medicines, including those available over-the-counter, and some herbal supplements can affect the levels of CAMZYOS in your body and may increase the risk of heart failure due to systolic dysfunction. Tell your prescriber, doctor or pharmacist about all the prescription medicines, over-the-counter medicines and herbal supplements you take, 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, herbal supplements and grapefruit juice, is not recommended.

Table 1: Examples of  medicines and products that may affect CAMZYOS

CAMZYOS and embryo-foetal 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 an 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 an effective method of contraception throughout treatment and for 6 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 be pregnant or are pregnant while receiving CAMZYOS, tell your prescriber or doctor immediately. Your prescriber or doctor will discuss your treatment options with you.