KYNAMRO (mipomersen sodium) injection Is Now Available

Administering KYNAMRO

Complete instructions for use of KYNAMRO in a single-use pre-filled syringe.

KYNAMRO Single-use Pre-filled Syringe Instructions for Use

Step One
Step Two
Step Three
Step Four
Step Five
Step Six
Step Seven
Step Eight

PREPARE: Step 1

Place supplies and wash hands.

Place the supplies you will need on a clean, flat surface in a well-lit area. Wash and dry your hands as well.

PREPARE: Step 2

Choose an injection site.

KYNAMRO is injected under the skin and into the fat layer between the skin and the muscles (subcutaneous). KYNAMRO should be injected in the abdomen (belly), thigh, or back of the upper arm. If you choose your abdomen, do not use the area 2 inches around your belly button (navel). NOTE: Choose a different site each time you give yourself an injection to reduce the chance of redness or pain. Avoid injecting KYNAMRO into areas of skin that are damaged, such as scars, tattoos, active skin disease, sunburns, rashes, inflammation, skin infections, or active areas of psoriasis.

PREPARE: Step 3

Clean the injection site.

Use an alcohol wipe and allow the site to dry.

PREPARE: Step 4

Remove the syringe from the tray.

Peel back the foil lid from the tray. Grab the syringe from the center and pull straight out of the tray. NOTE: Do not remove the syringe by pulling on the plunger or the cap as you may bend the needle or move the plunger. Allow KYNAMRO to come to room temperature before injecting.

INJECT: Step 5

Remove the cap.

Pull the cap straight off the syringe to avoid bending the needle. NOTE: Hold the barrel of the syringe in 1 hand like a pencil or a dart. Do not touch the needle.

INJECT: Step 6

Insert the needle.

Gently pinch and lift the skin around the injection site. Stick the needle straight down into your skin with a quick, firm motion. Be careful not to stick the needle into the fingers of your other hand.

INJECT: Step 7

Slowly, over a period of at least 10 seconds, push down the plunger with your thumb until the syringe is empty.

Once the syringe is empty, pull the needle straight out, release
the skin, and hold a clean cotton ball at the injection site. Do not rub the area because rubbing may cause reddening or pain at your
injection site.

INJECT: Step 8

Activate safety shield.

Point the needle down away from yourself and others, and
then fully push down on the plunger to activate the safety shield. Do not try to re-cap the needle with the cap.

 

In-home nurse visits are available for personalized injection training through KYNAMRO CornerstoneSM.

What is the most important information I should know about KYNAMRO?

  • KYNAMRO is available only through certified pharmacies that are enrolled in the KYNAMRO Risk Evaluation and Mitigation Strategy (REMS) Program.* Your doctor must be enrolled in the program in order for you to be prescribed KYNAMRO

How should I take KYNAMRO?

  • KYNAMRO is given by injection under your skin (subcutaneous) 1 time each week. KYNAMRO is available in single-use (1 time) vials, or as a single-use pre-filled syringe
  • Take KYNAMRO exactly as your doctor tells you to take it
  • Make sure that you or your caregiver are trained by your doctor or other healthcare professional in how to inject KYNAMRO the right way
  • Do not try to give yourself or have another person give you injections at home until you or both of you understand and are comfortable with how to prepare for your dose and give the injection
  • Take KYNAMRO on the same day of the week at the same time of day
  • It is important that KYNAMRO is at room temperature when it is injected
  • Do not mix KYNAMRO with other injectable medicines
  • Do not use KYNAMRO at the same time as other injectable medicines
  • If you use too much KYNAMRO, call your doctor right away
  • Do not stop taking KYNAMRO without talking to your doctor

What if I miss a dose?

  • If you miss a dose or forget to take your dose of KYNAMRO at your usual weekly time, you can take it when you remember, unless it is less than 3 days until your next weekly dose. If it is less than 3 days until your next weekly dose, wait and take your next weekly dose at your regularly scheduled time. Do not take a double dose at the same time to make up for a forgotten or missed dose

How should I store KYNAMRO?

  • Store KYNAMRO in a refrigerator between 36°F to 46°F (2°C to 8°C). If a refrigerator is not available, KYNAMRO can be stored at or below 86°F (30°C) for up to 14 days if it is kept away from heat
  • Protect KYNAMRO from light and store in the original carton
  • Safely throw away medicine that is out of date or no longer needed

Keep KYNAMRO and all medicines out of the reach of children.

*As a part of the KYNAMRO Risk Evaluation and Mitigation Strategy (REMS) program, your information may be collected and used according to FDA requirements.

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INDICATIONS

KYNAMRO (mipomersen sodium) injection is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis 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.
IMPORTANT SAFETY INFORMATION


WARNING: RISK OF HEPATOTOXICITY

KYNAMRO can cause elevations in transaminases. In the KYNAMRO clinical trial in patients with HoFH, 4 (12%) of the 34 patients treated with KYNAMRO compared with 0% of the 17 patients treated with placebo had at least one elevation in alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or partial thromboplastin time (PTT).

KYNAMRO also increases hepatic fat, with or without concomitant increases in transaminases. In the trials in patients with heterozygous familial hypercholesterolemia (HeFH) and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging (MRI). Hepatic steatosis is a risk factor for advanced liver disease; including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT, AST regularly as recommended. During treatment, withhold the dose of KYNAMRO if the ALT or AST are ≥3 x ULN. Discontinue KYNAMRO for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, KYNAMRO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS.

OTHER WARNINGS AND PRECAUTIONS

Patients are advised to read the KYNAMRO medication guide before starting treatment with KYNAMRO, and each time they receive a refill. There may be new information. This information does not take the place of talking to a doctor about a medical condition or treatment.

KYNAMRO may cause serious side effects, including liver problems. A doctor should be informed of any liver problems, including liver problems while taking other medicines, or if a patient has any of these symptoms of liver problems while taking KYNAMRO: nausea, vomiting, fever, loss of appetite, being (or feeling) more tired than usual, yellowing of eyes or skin, dark urine, itching, or stomach pain.

Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury. It is recommended that patients taking KYNAMRO should consume no more than one alcoholic drink per day.

Caution should be exercised when KYNAMRO is used with other medications known to have potential for hepatotoxicity.

KYNAMRO should be used during pregnancy only if clearly needed. Females who become pregnant during KYNAMRO therapy should notify their healthcare provider.

Safety and effectiveness have not been established in pediatric patients.

KYNAMRO is not recommended in patients with severe renal impairment, clinically significant proteinuria, or on renal dialysis.

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.

CONTRAINDICATIONS

KYNAMRO is contraindicated in the following conditions:

  • Moderate or severe hepatic impairment (Child-Pugh B or C) or active liver disease, including unexplained persistent elevations of serum transaminases.
  • Patients with a known hypersensitivity to any component of this product.

COMMON SIDE EFFECTS

In clinical trials the most commonly-reported adverse reactions were injection site reactions occurring in 84% of patients receiving KYNAMRO versus 33% of placebo treated patients. The most common injection site reactions were erythema (59%), pain (56%), hematoma (32%), pruritus (29%), swelling (18%) and discoloration (17%). Injection site reactions did not occur with every injection but resulted in discontinuation of therapy in 5% of patients in pooled phase 3 trials.

Flu-like symptoms, defined as any one of the following: influenza-like illness, pyrexia, chills, myalgia, arthralgia, malaise or fatigue and occurring within 2 days of injection, have been reported more frequently in patients receiving KYNAMRO (30%) versus placebo (16%) in the pooled Phase 3 trials. Flu-like symptoms did not occur with all injections but resulted in discontinuation of therapy in 3% of patients in pooled phase 3 trials.

See full Prescribing Information for more details about Warnings & Precautions, complete list of Adverse Reactions and Boxed Warning.