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Kynamro




PATIENT INFORMATION

KYNAMRO®
(kye-NAM-roe)
(mipomersen sodium) Injection

Read this Medication Guide before you start using KYNAMRO and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

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

  • KYNAMRO is available only through certified pharmacies that are enrolled in the KYNAMRO REMS Program. Your doctor must be enrolled in the program in order for you to be prescribed KYNAMRO.

KYNAMRO may cause serious side effects, including liver problems such as increased liver enzymes or increased fat in the liver.

  • Your doctor should do blood tests to check your liver before you start KYNAMRO.
  • Tell your doctor if you have had liver problems, including liver problems while taking other medicines.
  • Tell your doctor right away if you have any of these symptoms of liver problems while taking KYNAMRO:
    • nausea
    • vomiting
    • fever
    • loss of appetite
    • you are more tired than usual
    • yellowing of your eyes or skin
    • dark urine
    • itching
    • stomach pain
  • Drinking alcohol may increase your chance of having liver problems or make your liver problems worse. You should not have more than 1 alcoholic drink each day while using KYNAMRO.

What is KYNAMRO?

KYNAMRO is a prescription medicine used along with diet and other lipid-lowering treatments in people with homozygous familial hypercholesterolemia (HoFH) to reduce:

  • LDL (“bad”) cholesterol
  • total cholesterol
  • a protein that carries “bad” cholesterol in the blood (apolipoprotein B)
  • non-high-density lipoprotein cholesterol (non-HDL-C)

It is not known if KYNAMRO can decrease problems from high cholesterol, such as heart attack, stroke, death or other health problems.

It is not known if KYNAMRO is safe in people with high cholesterol but who do not have HoFH.

It is not known if KYNAMRO is safe and effective as an additional treatment to LDLapheresis.

It is not known if KYNAMRO is safe and effective in people with kidney and liver problems, including people who are on kidney dialysis.

It is not known if KYNAMRO is safe and effective when used in children under the age of 18.

Who should not take KYNAMRO?

Do not take KYNAMRO if you:

  • have moderate or severe liver problems or active liver disease, including people who have unexplained abnormal liver tests.
  • are allergic to mipomersen or any of the ingredients in KYNAMRO. See the end of this leaflet for a complete list of ingredients in KYNAMRO.

What should I tell my doctor before taking KYNAMRO?

Before you take KYNAMRO, tell your doctor if you:

  • have liver problems
  • have kidney problems
  • drink alcohol
  • are pregnant or plan to become pregnant. KYNAMRO may cause harm to your unborn baby. If you are a female who can get pregnant, you should use effective birth control while using KYNAMRO. Talk with your doctor to find the best method of birth control for you. If you become pregnant while taking KYNAMRO, stop taking KYNAMRO and call your doctor right away.
  • are breastfeeding or plan to breastfeed. It is not known if KYNAMRO passes into your breast milk. You and your doctor should decide if you will use KYNAMRO or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Before starting a new medicine while taking KYNAMRO, even if you will only be taking it for a short time, ask your doctor or pharmacist if it is safe to take while you are using KYNAMRO.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take KYNAMRO?

  • See the Instructions for Use that comes with this Medication Guide for complete information on how to use 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 on 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.
  • 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.
  • 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 are the possible side effects of KYNAMRO?

KYNAMRO can cause serious side effects, including:

  • See “What is the most important information I should know about KYNAMRO?”
  • injection site problems
  • flu-like symptoms

Call your doctor right away if you have any of the serious side effects of KYNAMRO.

The most common side effects of KYNAMRO include:

  • injection site problems. Skin reactions can happen in some people including redness or discoloration of the skin, pain, tenderness, itching, and swelling around the injection site. You may also get a reaction at a former site of injection, when injecting at a different site, or after an injury to an injection site.
  • flu-like symptoms, including fever, chills, aches, and tiredness. These symptoms usually happen within 2 days of an injection.
  • nausea
  • headache

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of KYNAMRO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

General information about KYNAMRO

Do not use KYNAMRO for a condition for which it was not prescribed. Do not give KYNAMRO to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about KYNAMRO. You can ask your pharmacist or doctor for information about KYNAMRO that is written for healthcare professionals.

For more information, go to www.KYNAMRO.com or call 1-877-KYNAMRO (1-877596-2676).

What are the ingredients in KYNAMRO?

Active ingredient: mipomersen sodium

Inactive ingredients: sterile water, hydrochloric acid, and sodium hydroxide This Medication Guide has been approved by the U.S. Food and Drug Administration.

INSTRUCTIONS FOR USE

KYNAMRO®
(kye-NAM-roe)
(mipomersen sodium) injection Solution for Subcutaneous Injection Single-use Pre-filled Syringe

Read the Instructions for Use that come with your KYNAMRO before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment. Before you use KYNAMRO for the first time, make sure your doctor shows you the right way to use it.

This Instructions for Use is only to be used for KYNAMRO in pre-filled syringes.

Do not use the KYNAMRO pre-filled syringe if:

  • the expiration date on the barrel of the container has passed.
  • the packaging or seals are torn or broken, or the syringe looks cracked or damaged when you receive your KYNAMRO.
  • the medicine in the pre-filled syringe is discolored (it should be colorless to slightly yellow), or if it is cloudy or has any visible particles in it (it should be completely clear).

Supplies needed for your KYNAMRO injection:

  • KYNAMRO pre-filled syringe
    • NOTE: It is important that KYNAMRO be at room temperature prior to the injection. Allow KYNAMRO to come to room temperature for at least 30 minutes. When KYNAMRO is cold, it may cause redness or sensitivity after your injection. KYNAMRO should not be heated and should be kept in original packaging to protect from light.
  • alcohol wipe
  • cotton ball
  • puncture-proof container to dispose of the used syringes. See the detailed instructions for the “Dispose of used syringes” at the end of this Instructions for Use.

The figure below shows what the pre-filled syringe for KYNAMRO looks like before and after use.

KYNAMRO pre-filled syringe - Illustration

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 well.

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.

Choose an injection site - Illustration

Step 3. Clean the injection site. Use an alcohol wipe and allow the site to dry.

Clean the injection site - Illustration

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.

Remove the syringe from the tray - Illustration

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.

Pull the cap straight off the syringe - Illustration

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.

Stick the needle straight down - Illustration

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.

push down the plunger - Illustration

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.

Activate safety shield - Illustration

DISPOSE:

Step 9. Dispose of used syringes.

  • Put your used syringes in a FDA-cleared sharps disposal container right away after use.
  • Do not throw away (dispose of) loose syringes in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic
    • can be closed with a tight-fitting, puncture-proof lid, without sharps being able to come out
    • upright and stable during use
    • leak resistant
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

INSTRUCTIONS FOR USE

KYNAMRO®
(kye-NAM-roe)
(mipomersen sodium) injection Solution for Subcutaneous Injection Single-use Vial

Read the Instructions for Use that come with your KYNAMRO before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment. Before you use KYNAMRO for the first time, make sure your doctor shows you the right way to use it.

This Instructions for Use is only to be used for KYNAMRO single-use vials for injection.

Do not use the KYNAMRO vial if:

  • the expiration date on the container has passed.
  • the packaging or seals are torn or broken, or the vial looks cracked or damaged when you receive your KYNAMRO.
  • the medicine in the vial is discolored (it should be colorless to slightly yellow), or if it is cloudy or has any visible particles in it (it should be completely clear).

Supplies needed for your KYNAMRO injection:

  • KYNAMRO vial
    • NOTE: It is important that KYNAMRO be at room temperature prior to the injection. Allow KYNAMRO to come to room temperature for at least 30 minutes. When KYNAMRO is cold, it may cause redness or sensitivity after your injection. KYNAMRO should not be heated and should be kept in original packaging to protect from light.
  • 2 new needles (Note: the needle with the higher gauge number is smaller):
    • 22-gauge needle
    • 30-gauge needle
  • 1 mL sterile syringe
  • 2 alcohol wipes
  • cotton ball
  • puncture-proof container to dispose of the needles, syringe, and vial. See the detailed instructions for “Dispose of used syringes, needles, and vials” at the end of this Instructions for Use.

The figure below shows the KYNAMRO vial, the sterile syringe, and the needles that you will need.

Supplies needed for your KYNAMRO injection -  Illustration

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 well.

Step 2. Remove vial cap. With your thumb, push up and remove the plastic protective cap (see Figure A). Clean the rubber stopper with a fresh alcohol wipe (see Figure B). Allow the alcohol to dry for 15 seconds to 30 seconds.

Remove vial cap - Illustration

Step 3. Attach 22-gauge or larger needle. Put a sterile 22-gauge or larger needle, with the cap still on, onto a new syringe.

Attach 22-gauge or larger needle - Illustration

Step 4. Prepare syringe for insertion into vial.

a. Pull the cap straight off the needle to avoid bending the needle (see Figure C). NOTE: Hold the barrel of the syringe in one hand like a pencil or a dart. Do not touch the needle.

Pull the cap straight off the needle - Illustration

b. Pull the plunger back, filling the syringe with air to the 0.5 mL unit marking (see Figure D).

Fill the syringe with air to the 0.5 mL unit marking - Illustration

Step 5. Insert syringe needle into vial. Push the needle through the rubber stopper and push the plunger to put air into the air space above the liquid.

Insert syringe needle into vial - Illustration

Step 6. Fill syringe. Turn the vial upside down. Position the syringe so the needle is in the liquid. Pull back on the plunger to fill the syringe to the 1 mL mark. NOTE: Make sure the needle remains in the liquid while drawing the medicine into the syringe.

Draw the required dose - Illustration

Step 7. Check the syringe.

a. Remove the syringe from the vial.

b. Check for air bubbles in the syringe by gently tapping on the syringe with your fingertips to make any air bubbles rise to the top (see Figure E).

c. With your other hand gently push the plunger to remove the air bubbles without accidently pushing out the medicine.

d. Check to be sure that the right amount of medicine is in the syringe. If needed, repeat the steps above until 1 mL of the medicine is in the syringe without air bubbles (see Figure F).

Check for air bubbles - Illustration

Step 8. Remove and dispose of needle. Remove the needle from the syringe and carefully throw away the needle in a puncture-proof container.

Step 9. Attach 30-gauge needle. Put a 30-gauge needle onto the syringe (see Figure G) and remove the cap by pulling it straight off the syringe to avoid bending the needle (see Figure H). NOTE: Hold the barrel of the syringe in one hand like a pencil or a dart. Do not touch the needle itself.

Attach 30-gauge needle - Illustration

Step 10. Choose an injection site. KYNAMRO is injected under the skin and into the fat layer between the skin and muscles (subcutaneous tissue). 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.

Choose an injection site - Illustration

INJECT:

Step 11. Clean the injection site. Use an alcohol wipe and allow the site to dry.

Clean the injection site - Illustration

Step 12. 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.

Insert the needle - Illustration

Step 13. 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.

Push down the plunger - Illustration

DISPOSE:

Step 14. Dispose of used syringes, needles and vials.

  • Put your used needles, syringes, and vials in a FDA-cleared sharps disposal container right away after use.
  • Do not throw away (dispose of) loose needles, syringes, or vials in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic
    • can be closed with a tight-fitting, puncture-proof lid, without sharps being able to come out
    • upright and stable during use
    • leak resistant
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/13/2015
This monograph has been modified to include the generic and brand name in many instances.

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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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