July 27, 2016
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Kynamro

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Nov. 1, 2013 -- The cholesterol-lowering drug Crestor (rosuvastatin) was the nation's most prescribed drug in the past 12 months, according to a new report from research firm IMS Health. New "...

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Kynamro




Indications
Dosage
How Supplied

INDICATIONS

KYNAMRO® is indicated as an adjunct to lipid-lower in g medications and diet to reduce low density lipoprote in-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, including those with heterozygous familial hypercholesterolemia (HeFH).
  • 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. Monitor transaminases during treatment with KYNAMRO as described in Warnings and P recautions (5.1), and withhold the dose for patients who develop transaminase values > 3x the upper limit of normal (ULN) during treatment with KYNAMRO [see Adjustments For Patients Developing Transaminase Elevations].

Administration

Each 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 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 Transaminases

ALT or AST Treatment and monitoring recommendations*
≥ 3x and < 5x ULN
  • Confirm elevation with a repeat measurement within one week.
  • If confirmed, withhold dosing, obtain additional liver-related tests if not already measured (such as total bilirubin, alkaline phosphatase and INR) and investigate to identify the probable cause.
  • If res umin g KYNAM RO after tran s aminases resolve to < 3x ULN consider monitoring liver-related tests more frequently.
≥ 5x ULN
  • Withhold dosing, obtain additional liver-related tests if not already meas ured (such as total bilirubin, alkalin ephosphatase and INR) and investigate to identify the probable cause.
  • If resuming KYNAMRO after transaminases resolveto < 3x ULN, monitor liver-related tests more frequently.
* 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].

HOW SUPPLIED

Dosage Forms And Strengths

  • 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, 1 mL, clear pre-filled syringes with staked needles. Each 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 pre-filled syringes.

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 credits, for up to 14 days. Do not use KYNAMRO after the expiration date on the label.

KYNAMRO is manufactured for: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142. Revised: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/7/2016

Indications
Dosage
How Supplied

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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