General Dosing Information

Before beginning treatment with KYNAMRO, measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin [see Warnings and Precautions (5.1)].

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 Precautions (5.1​), and withhold the dose for patients who develop transaminase values >3x the upper limit of normal (ULN) during treatment with KYNAMRO [see Dosage and Administration (2.3​)​].

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 (5.1)].

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 (5.1)].