Gamimune N

Name: Gamimune N

Notes

Laboratory and/or medical tests (e.g., complete blood count, kidney/liver function tests, urine volume) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

Commonly used brand name(s)

In the U.S.

  • Baygam
  • Bivigam
  • Carimune
  • Cuvitru
  • Flebogamma 10% DIF
  • Flebogamma 5%
  • Flebogamma 5% DIF
  • Gamastan S/D
  • Gamimune N
  • Gammagard
  • Gammagard S/D
  • Gammaplex
  • Gammaplex 10%
  • Gammar-P
  • Gamunex
  • Hizentra
  • Iveegam EN
  • Octagam
  • Octagam 10%
  • Panglobulin NF
  • Polygam S/D
  • Privigen
  • Sandoglobulin
  • Venoglobulin-S
  • Vivaglobin

Available Dosage Forms:

  • Solution
  • Powder for Solution

Therapeutic Class: Immune Serum

Uses For Gamimune N

Immune globulin injection is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), chronic immune thrombocytopenic purpura, or chronic inflammatory demyelinating polyneuropathy (CIDP). It is also used to improve muscle strength and disability in patients with multifocal motor neuropathy (MMN). Immune globulin injection belongs to a group of medicines known as immunizing agents.

This medicine is to be given only by or under the supervision of your doctor.

Proper Use of immune globulin

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Gamimune N. Please read with care.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gammaked™, Gamunex®-C, and Hizentra® products may be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. The Hizentra® product may also be given once every 2 weeks. If you are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. You will be shown the body areas where the medicine can be given. Use a different body area for each infusion. Keep track of where you give an infusion to make sure you rotate sites. This will help prevent skin problems.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you must change the brand of medicine, talk to your doctor before giving yourself an infusion. Make sure you understand the instructions on how to use the new brand.

Allow the Gammagard Liquid, Gammaked™, or Gamunex®-C brand to reach room temperature before using it.

To use Gammagard Liquid, Gammaked™, Gamunex®-C, or Hizentra®:

  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
  • Wash your hands with soap and water before and after using this medicine.
  • If you have been told to wear gloves when preparing your infusion, put the gloves on.
  • Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.
  • If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.
  • Follow your doctor's instructions on how to prepare the correct amount of medicine.
  • Choose an injection site on your body (eg, abdomen or stomach area, thigh, upper arm, upper leg, hip). Clean the injection site with a fresh alcohol wipe, and let it dry.
  • With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.
  • Put sterile gauze and tape over the injection site to keep the needle from coming out.
  • Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.
  • Follow your doctor's instructions on how to use the infusion pump.
  • Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.
  • It usually takes about 60 minutes for each infusion.
  • When all of the medicine has been infused, turn off the pump.
  • Take the gauze off and remove the needle and tube from your skin.
  • Clean and store the infusion pump.
  • Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture, for up to 30 months. Keep from freezing. Protect the product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C product in the original container and in the refrigerator, but do not freeze it.

You may store the Gammagard Liquid or Gammaked™ product in the refrigerator or at room temperature. Check the box or label of the vials for expiration dates. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Gamimune N Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Chills
  • cough
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • noisy breathing
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Less common
  • Bluish coloring of the lips or nail beds
  • burning sensation in the head
  • faintness or lightheadedness
Rare
  • Difficulty with swallowing
  • hives or welts
  • itching, especially of the feet or hands
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
Incidence not known
  • Back, leg, or stomach pains
  • blistering, peeling, or loosening of the skin
  • change in vision
  • changes in urination
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • convulsions
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • headache that is severe and occurs suddenly
  • light-colored stools
  • loss of consciousness
  • low blood pressure or pulse
  • muscle spasm or jerking of all extremities
  • nausea or vomiting
  • pains in the chest, groin, or legs, especially calves of the legs
  • shakiness in the legs, arms, hands, or feet
  • skin blisters
  • slow breathing
  • slurred speech that occurs suddenly
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden, severe weakness or numbness in the arm or leg
  • sweating
  • swelling in the legs and ankles
  • tightness in the chest
  • unusual bleeding or bruising
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle pain
  • redness, swelling, itching, or pain at the injection site
  • skin rash
Less common
  • Hip pain
  • leg cramps
Incidence not known
  • Feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain
  • swollen glands
  • tiredness
  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

(web3)