GamaSTAN (Intramuscular, Intravenous, Subcutaneous)

Immune globulin injection is used to prevent infections or reduce the severity of infections (for example, hepatitis A if exposed within 2 weeks, chickenpox, measles if exposed within 6 days, if you have not been vaccinated and have not had measles before, or rubella) when your immune system is weak. Immune globulin contains antibodies that help boost your immune system. It is used for patients with primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), chronic immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy (CIDP), or dermatomyositis (DM). It is also used to improve muscle strength and disability in patients with multifocal motor neuropathy (MMN). Immune globulin injection is part of a group of medicines called immunizing agents.

This medicine should only be given by your doctor or under their supervision.

It is very important for your doctor to check your progress during regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gammaked™ or Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or light sensitivity. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you have stomach or back pain, dark urine, decreased urination, difficulty breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you start having chest pain, difficult, fast, or noisy breathing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, trouble breathing, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung problem, including transfusion-related acute lung injury (TRALI).

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, severe headache, leg pain, or problems with vision, speech, or walking.

Check with your doctor right away if you start having red or dark brown urine, lower back or side pain, sudden weight gain, swollen face, arms, or legs, decreased urine output, or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You may need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Current studies have not shown any specific problems for children that would limit the usefulness of immune globulin injection. Some products are only for children aged 2, 3, or 15 years and older, and other products are not approved for children. Immune globulin injection is used to treat primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic immune thrombocytopenic purpura in children. Safety and effectiveness have not been established for chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), or dermatomyositis (DM).

Studies have not been done to see how age affects the use of Gamastan® in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems for older adults that would limit the usefulness of immune globulin injection. However, older patients may have age-related blood clotting issues, kidney disease, or heart disease, which may require caution when receiving immune globulin injection.

Studies have not been done to see how age affects the use of Gamastan® in older adults. Safety and effectiveness have not been established.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the following medicines. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Pozelimab-bbfg
• Ravulizumab-cwvz

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to corn—Use with caution. May cause an allergic reaction.

• Anemia, history of or
• Bleeding problems, history of or
• Hyponatremia (low sodium in the blood) or
• Kidney problems—Use with caution. May worsen these conditions.

• Atherosclerosis (hardening of the arteries), history of or
• Blood clotting problems, history of or
• Diabetes or
• Recent heart attack or stroke or
• Heart or blood vessel disease or
• Hyperproteinemia (high protein in the blood) or
• Hyperviscosity (thick blood), known or suspected or
• Hypovolemia (low blood volume or major loss of body fluids) or
• IgA (immunoglobulin A) deficiency with antibodies against IgA or
• Paraproteinemia (paraproteins in the blood) or
• Sepsis (serious infection in the body)—Use with caution. May worsen side effects.

• Hereditary intolerance to fructose or sucrose or
• IgA (immunoglobulin A) deficiency with antibodies against IgA—Gammaplex® should not be used in these patients.

• Hyperprolinemia (too much proline in the blood) or
• IgA (immunoglobulin A) deficiency with antibodies against IgA—Hizentra® and Privigen® should not be used in these patients.

• IgA (immunoglobulin A) deficiency with antibodies against IgA—Cuvitru®, Gamastan®, and Octagam® should not be used in these patients.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Back pain
• black, tarry stools
• blurred vision
• bone pain
• chest pain or tightness
• chills
• cough
• dark urine
• decreased urination
• diarrhea
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• noisy breathing
• pain in the arms or legs
• painful or difficult urination
• pounding in the ears
• rash
• runny nose
• shivering
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• sweating
• swollen glands
• trouble breathing
• trouble sleeping
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

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
• blood in the urine
• change in vision
• changes in blood pressure
• changes in urination
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• decreased frequency or amount of urine
• difficult or labored breathing
• difficulty seeing at night
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• headache that is severe and occurs suddenly
• hoarseness
• increased sensitivity of the eyes to sunlight
• increased thirst
• irritation
• joint stiffness or swelling
• light-colored stools
• loss of appetite
• loss of consciousness
• low blood pressure or pulse
• lower back or side pain
• muscle spasm or jerking of all extremities
• pains in the chest, groin, or legs, especially calves of the legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• skin blisters
• slow breathing
• slurred speech that occurs suddenly
• sudden, severe weakness or numbness in the arm or leg
• sweating
• swelling of the face, fingers, lower legs, or ankles
• weight gain

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

More common

• Lack or loss of strength
• redness, swelling, itching, or pain at the injection site

Less common

• Hip pain
• leg cramps

Incidence not known

• Anxiety
• dry mouth
• hair loss, thinning of hair
• nervousness

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

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

In the U.S.

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

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Immune Serum

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into 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 to 6 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. Cuvitru® and Hizentra® products 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 Cuvitru®, 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, 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.

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 Hizentra® 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 its original package until you are ready to use it.

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

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

Store Cuvitru® at room temperature, away from heat and moisture, for up to 24 months or in the refrigerator for up to 36 months. Do not freeze. Do not shake. Protect the product from direct light. Keep the medicine in its original package until you are ready to use it.

Throw away used needles and tubes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.