evolocumab

Repatha

GENERIC AVAILABLE: No

Yes

• Repatha is used along with diet, exercise and maximum tolerated doses of statins to reduce LDL cholesterol in adults with heterozygous familial hypercholesterolemia (and inherited disorder that causes high levels of LDL) or adults with heart problems related to excess cholesterol in the body.
• Repatha is also used along with diet and other LDL-lowering treatments, for example, statins, ezetimibe (Zetia) and LDL apheresis, to reduce cholesterol in people with homozygous familial hypercholesterolemia (an inherited disorder that causes high levels of LDL).

The most common side effects associated with Repatha treatment include

• injection site reactions,
• back pain,
• symptoms of the common cold, and
• flu-like symptoms.

Other side effects include

• diarrhea,
• muscle pain,
• muscle spasm,
• fatigue,
• urinary tract infections (UTIs),
• cough,
• allergic reactions,
• hypertension,
• headache,
• dizziness,
• joint pain,
• nausea,
• confusion, and
• pancreatitis

A more serious side effect is:

• Hypersensitivity reactions: Repatha should not be used in patients with a history of serious hypersensitivity reactions to the product. Hypersensitivity reactions include itching, rash, and hives, have occurred. Repatha should be discontinued if signs or symptoms of serious allergic reactions occur.

• The recommended subcutaneous dose for patients with heterozygous familial hypercholesterolemia or adults with heart problems related to excess cholesterol in the body is either 140 mg every 2 weeks or 420 mg once monthly.
• The recommended subcutaneous dosage in patients with homozygous familial hypercholesterolemia is 420 mg once monthly. LDL cholesterol levels should be measured 4 to 8 weeks after starting Repatha since response to therapy will depend on the degree of LDL-receptor function.
• LDL cholesterol levels should be measured within 4 to 8 weeks of starting therapy to assess response to treatment, and a decision should be made whether or not to adjust the dose.
• Repatha should only be injected subcutaneously into the thigh, abdomen, or upper arm. Injection sites should be rotated among different sites to prevent or reduce injection site reactions and irritation. Repatha should not be co-administered with other injectable drugs at the same injection site.

No clinically significant drug-drug interactions are known for Repatha.

• There is no data on the use of Repatha in pregnant women.
• It is not known if Repatha is secreted in human milk or whether it can cause harm to the nursing infant.

What preparations of evolocumab are available?

Single-use pre-filled syringe and single-use pre-filled Sureclick autoinjector, each designed to deliver 1 ml of 140 mg/ml solution.

How should I keep evolocumab stored?

Repatha should be stored in the refrigerator at 2 C to 8 C (36 F to 46 F) and protected from light. It should not be frozen.