"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
KYNAMRO® is indicated as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
Limitations of Use
- The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH.
- The effect of KYNAMRO on cardiovascular morbidity and mortality has not been determined.
- The safety and effectiveness of KYNAMRO as an adjunct to LDL apheresis have not been established; therefore, the use of KYNAMRO as an adjunct to LDL apheresis is not recommended.
DOSAGE AND ADMINISTRATION
General Dosing Information
Before beginning treatment with KYNAMRO, measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin [see WARNINGS AND PRECAUTIONS].
The recommended dose of KYNAMRO is 200 milligrams (mg) once weekly as a subcutaneous injection.
KYNAMRO is intended for subcutaneous use only. Do not administer intramuscularly or intravenously.
The injection should be given on the same day every week, but if a dose is missed, the injection should be given at least 3 days from the next weekly dose.
After initiation of KYNAMRO therapy lipid levels should be monitored at least every 3 months for the first year. Maximal reduction of LDL-C may be seen with KYNAMRO therapy after approximately 6 months (based on the time to steady state seen in clinical studies). Health care providers should assess the patient’s LDL-C level after 6 months to determine if the LDL-C reduction achieved with KYNAMRO is sufficiently robust to warrant the potential risk of liver toxicity.
Each vial or pre-filled syringe of KYNAMRO provides 200 mg of mipomersen sodium in a deliverable volume of 1 milliliter (mL) of solution and is intended for single-use only.
The KYNAMRO vial or pre-filled syringe should be removed from 2-8°C (36-46°F) refrigerated storage and allowed to reach room temperature for at least 30 minutes prior to administration.
Parenteral drug products should be inspected visually prior to administration. If the solution is cloudy or contains visible particulate matter, the contents must not be injected and the product should be returned to the pharmacy.
The first injection administered by the patient or caregiver should be performed under the guidance and supervision of an appropriately qualified health care professional.
KYNAMRO should be injected into the abdomen, thigh region, or outer area of the upper arm. KYNAMRO should not be injected in areas of active skin disease or injury such as sunburns, skin rashes, inflammation, skin infections, active areas of psoriasis, etc. Areas of tattooed skin and scarring should also be avoided.
Adjustments For Patients Developing Transaminase Elevations
Table 1 summarizes recommendations for monitoring for patients who develop elevated transaminases during therapy with KYNAMRO [see WARNINGS AND PRECAUTIONS].
Table 1: Monitoring for Patients With Elevated
|ALT OR AST||Treatment and monitoring recommendations*|
|≥ 3x and < 5x ULN||
|≥ 5x ULN||
|* Recommendations based on an ULN of approximately 30-40 international units/L.|
If transaminase elevations are accompanied by clinical symptoms of liver injury (e.g., nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with KYNAMRO and investigate to identify the probable cause [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
- Single-use vial containing 1 mL of a 200 mg/mL clear, colorless to slightly yellow solution.
- Single-use pre-filled syringe containing 1 mL of a 200 mg/mL clear, colorless to slightly yellow solution.
Storage And Handling
KYNAMRO is supplied in single-use, 2 mL, clear glass vials or single-use, 1 mL, clear pre-filled syringes with staked needles. Each single-use vial or single-use pre-filled syringe of KYNAMRO is filled to deliver 1 mL of 200 mg/mL solution containing 200 mg of mipomersen sodium.
KYNAMRO is available in cartons containing 1 or 4 vials and 1 or 4 pre-filled syringes.
Pack of 1 vial: NDC
Pack of 4 vials: NDC 58468-0190-2
Pack of 1 pre-filled syringe: NDC 58468-0191-1
Pack of 4 pre-filled syringe: NDC 58468-0191-2
Store refrigerated KYNAMRO at 2-8 °C (36-46 °F). KYNAMRO should be protected from light and kept in the original carton until time of use. When refrigeration is not available KYNAMRO may be stored at or below 30 °C (86 °F), away from heat sources, for up to 14 days. Do not use KYNAMRO after the expiration date on the label. This product contains no preservatives; any unused drug remaining in vial after extracting 1 mL for injection must be safely discarded.
KYNAMRO vials manufactured by: Hospira Inc. McPherson, KS 67460, KYNAMRO pre-filled syringes manufactured by: Genzyme Biosurgery Ridgefield, NJ 07657. KYNAMRO is manufactured for: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 1-800-745-4447 (phone). Issued: January 2015
Last reviewed on RxList: 3/13/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Kynamro Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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