Repatha Injection
Evolocumab
140mg/ml
Amgen Europe B.V
| Pack size | 1 Pre-filled Pen |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | PHARMATRADE |
| Retail Price | 1129.50 AED |
Available as:
Indications
Repatha Injection is used for:
Indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization, Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic CVD, who require additional lowering of LDL-C
Adult Dose
Subcutaneous
Heterozygous familial hypercholesterolaemia, Mixed dyslipidaemia, Nonfamilial hypercholesterolaemia
Adult: As monotherapy or in combination with statins and other lipid-lowering drugs:
140 mg once every 2 weeks or 420 mg once monthly.
Subcutaneous
Familial homozygous hypercholesterolaemia
Adult: In combination with other lipid-lowering drugs: Initially, 420 mg once monthly.
May be increased if necessary, after 12 weeks, to 420 mg once every 2 weeks.
Patients on apheresis:
420 mg once every 2 weeks.
Hepatic impairment
Mild or moderate: No dose adjustment required
Severe: Not studied
Child Dose
Subcutaneous
Homozygous Familial Hypercholesterolemia
Indicated as an adjunct to diet and other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C
<13 years: Safety and efficacy not established
13-17 years: 420 mg SC once monthly
Renal Dose
Renal impairment
Mild or moderate: No dose adjustment required
Severe: In a clinical trial, reductions in PCSK9 levels in patients with severe renal impairment or ESRD receiving hemodialysis was similar to those with normal renal function
Administration
SC Preparation
Remove prescribed dose from refrigerator at least 30 minutes before administration; this helps administer the entire dose and minimizes injection discomfort
Do not heat syringe, autoinjector, or on-body infuser (eg, microwave or hot water); let them warm to room temperature on their own
Do not leave in direct sunlight; keep in original carton until administered
SC Administration
Available as 140-mg/mL prefilled syringe or autoinjector; also available as 420-mg/3.5-mL on-body infusor
420 mg dose: Give three 140-mg SC injections consecutively within 30 minutes OR over 9 minutes using the single-use on-body infusor with refilled cartridge
Clean injection site with alcohol wipe and let dry
Do not inject in areas of skin that are bruised, red, tender, or hard
Avoid injecting in scars or stretch marks
Rotate administration sites
Administration sites
Self-injection: Thigh or abdomen (except for a 2-inch area around the naval)
Caregiver: Thigh, abdomen, or outer area of upper arm
Contra Indications
History of serious hypersensitivity to evolocumab
Precautions
Hypersensitivity reactions (eg, rash, urticaria) reported, including some that led to discontinuation of therapy; if signs or symptoms of serious allergic reactions occur, discontinue treatment, treat accordingly and monitor until signs and symptoms resolve. Renal and hepatic impairment.
Lactation
Unknown if distributed in human breast milk
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant
Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts
Pregnancy-Lactation
Pregnancy
No available data on use in pregnant women
Monoclonal antibodies in humans indicate that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimesters
Pregnancy outcomes in women exposed to evolocumab during pregnancy are monitored by the pregnancy exposure registry, 1-877-311-8972 or https://mothertobaby.org/ongoing-study/repatha/
Animal studies
No effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dosage
In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses
Lactation
Unknown if distributed in human breast milk
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant
Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts
Interactions
Adverse Effects
Side effects of Evolocumab :
>10%
Nasopharyngitis (4-10.5%)
1-10%
Upper respiratory tract infection (2.1-9.3%)
Influenza (1.2-7.5%)
Back pain (2.3-6.2%)
Injection site reactions (3.2-5.7%)
Allergic reaction (5.1%)
Cough (1.2-4.5%)
Urinary tract infection (1.3-4.5%)
Sinusitis (4.2%)
Headache (4%)
Myalgia (4%)
Dizziness (3.7%)
Musculoskeletal pain (3.3%)
Hypertension (3.2%)
Diarrhea (3%)
Gastroenteritis (3%)
Arthralgia (1.8%)
Nausea (1.8%)
Fatigue (1.6%)
Muscle spasms (1.3%)
Contusion (1%)
Mechanism of Action
Evolocumab is a human monoclonal antibody (IgG2 isotype) that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). It inhibits PCSK9 from binding to LDL receptors in the liver thereby increasing receptor numbers, leading to increased uptake of LDL-cholesterol hence lowering its level in the blood.
Note
Repatha 140mg/ml Injection manufactured by Amgen Europe B.V. Its generic name is Evolocumab. Repatha is availble in United Arab Emirates.
Farmaco UAE drug index information on Repatha Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.