صيدلية اونلاين

REPATHA PEN 140 MG ( 2

$3,478.94 $940.25

Affecting Nutrition and Metabolism
Metabolic Diseases
ACTIVE INGREDIENTS
= Additional active ingredients
Evolocumab 140 mg.
EVOLOCUMAB
PRESENTATION AND DOSSAGE
PRE-FILL.SYR.: 1, 2, 3, 6.
RELATED INFORMATION

INDICATIONS
Hypercholesterolaemia and mixed dyslipidaemia: Evolocumab is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed yslipidaemia, as an adjunct to diet: In combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin or, Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Homozygous familial hypercholesterolaemia: Evolocumab is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. The effect of Evolocumab on cardiovascular morbidity and mortality has not yet been determined.

DRUG INTERACTION
No formal drug-drug interaction studies have been conducted for Evolocumab. No studies on pharmacokinetic and pharmacodynamics interaction between Evolocumab and lipid-lowering drugs other than statins and ezetimibe have been conducted.
See prescribing information for full details.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

SPECIAL PRECAUTIONS
Renal impairment: Patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) have not been studied. Evolocumab should be used with caution in patients with severe renal impairment.
Hepatic impairment: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL‑C reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Evolocumab should be used with caution in patients with severe hepatic impairment.
Dry natural rubber: The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium‑free’.
See prescribing information for full details.

SIDE EFFECTS
Influenza, nasopharyngitis, upper respiratory tract infection, rash urticaria nausea back pain, arthralgia injection site reactions.
See prescribing information for full details

DOSAGE
Primary hypercholesterolaemia and mixed dyslipidaemia in adults: The recommended dose of Evolocumab is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over: The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up‑titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment, for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment, for patients with moderate and severe hepatic impairment.
Elderly patients (age ≥ 65 years): No dose adjustment is necessary in elderly patients.
Paediatric population: The safety and efficacy of Evolocumab in children aged less than 18 years has not been established in the indication for primary hypercholesterolaemia and mixed dyslipidaemia. No data are available. The safety and efficacy of Evolocumab in children aged less than 12 years has not been established in the indication for homozygous familial hypercholesterolaemia. No data are available.

OVERDOSE
No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Evolocumab at 420 mg once monthly. There is no specific treatment for Evolocumab overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.

PREGNANCY & LACTATION
Pregnancy: There are no or limited amount of data from the use of Evolocumab in pregnant women. 
Lactation: It is unknown whether evolocumab is excreted in human milk.
See prescribing information for full details.

IMPORTANT NOTES
Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe in the original carton in order to protect from light. If removed from the refrigerator, Evolocumab may be stored at room temperature (up to 25°C) in the original carton and must be used within 7 days.
Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

MANUFACTURER & DISTRIBUTER:
Manufacturer: Amgen Europe B.V., Breda, Netherlands.
License Holder: Amgen Europe

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