Black Box Warnings .
restricted distribution program (KYNAMRO REMS) due to hepatotoxicity risk; prescribers, pharmacies must be certified; 1-877-596-2676 or www.kynamrorems.com for more information
ALT incr. >3x ULN in 12% of pts in clinical trial; no clinically meaningful incr. in total bilirubin, INR, PTT observed; hepatic fat incr. from 0% to 10% after 26wk of tx; mipomersen-assoc. hepatic steatosis is risk factor for progressive hepatic dz, incl. steatohepatitis and cirrhosis; monitor LFTs at baseline, then at least ALT/AST regularly as recommended; hold dose if ALT/AST >3x ULN; D/C tx for clinically significant hepatotoxicity
Adult Dosing .
Dosage forms: SC
Restricted Distribution in US
- [1-877-596-2676 or www.kynamrorems.com for more info]
homozygous familial hypercholesterolemia
- [200 mg SC qwk]
- [not defined]
- [see below]
- mild impairment: not defined; mod-severe impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
- hypersens. to drug/class/compon.
- hepatic impairment, mod-severe
- hepatic dz, active
- elevated LFTs, unexplained
- caution if alcohol abuse
Drug Interactions .
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
- hypersensitivity rxn
- neoplasm, malignant
- injection site rxn
- influenza-like sx
- ALT, AST incr.
- hepatic steatosis
- extremity pain
- peripheral edema
- musculoskeletal pain
- abdominal pain
Lactation: Safety Unknown
LFTs at baseline, then at least ALT/AST qmo x12mo, then q3mo
Metabolism: tissues; CYP450: none
Excretion: urine; Half-life 1-2mo
Subclass: Dyslipidemia: Other
Mechanism of Action
selectively inhibits translation of apo B-100 mRNA, preventing formation of LDL and VLDL
Manufacturer: Genzyme Corp.
Approximate Retail Price
This information is currently not available for this drug.
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