Flebogamma 5% (Intramuscular, Intravenous, Subcutaneous)

Immune globulin injection is used to prevent infections or reduce the severity of infections (for example, hepatitis A with no more than 2 weeks of exposure, chickenpox, measles with no more than 6 days of exposure, for those who have not been vaccinated, and have not had measles before, or rubella) when your immune system is weak. Immune globulin contains antibodies that help strengthen your immune system. It is used for patients who have 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 enhance muscle strength and reduce 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 at regular visits for any issues that may be caused by this medicine. Blood and urine tests may be needed to look for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not receive Gammaked™ or Gamunex®-C injected under the skin (subcutaneously). This may increase the risk of developing a hematoma (a 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 had it for more than 8 weeks. Contact 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 received them, although the risk is low. Both human donors and donated blood are tested for viruses to reduce the risk of transmission. Discuss any concerns about this risk with your doctor.

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

Contact your doctor right away if you develop a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or sensitivity to light. These could indicate a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Notify your doctor immediately if you experience stomach or back pain, dark urine, decreased urination, difficulty breathing, an increased heart rate, tiredness, or yellowing of your eyes or skin after receiving the medicine.

Contact your doctor right away if you experience chest pain, difficulty breathing, fast or noisy breathing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces 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 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 due to surgery or illness. Contact your doctor immediately if you suddenly experience chest pain, severe headache, leg pain, or problems with vision, speech, or walking.

Contact your doctor right away if you develop 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 receiving this medicine. These may be symptoms of a serious kidney problem.

Your blood pressure may increase while using this medicine. This could cause headaches, dizziness, or blurred vision. You may need to measure your blood pressure at home. If you believe your blood pressure is too high, call your doctor immediately.

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 and benefits. For this medicine, please think about the following:

Allergies

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

Pediatric

Studies have not shown any specific problems that would limit the use of immune globulin injection in children. Some products are only for children aged 2, 3, or 15 years and older, while others 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 conducted on the effects of Gamastan® in children. Safety and effectiveness have not been established.

Geriatric

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

Studies have not been conducted on the effects of Gamastan® in older adults. Safety and effectiveness have not been established.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while receiving this medicine. The interactions listed below are based on their potential importance and may not be all-inclusive.

Using this medicine with the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Pozelimab-bbfg
• Ravulizumab-cwvz

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating 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 issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, 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 intended effects, a medicine can cause some unwanted effects. Not all of these side effects will occur, but if they do, they might need medical attention.

Check with your doctor or nurse immediately 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 gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Talk to 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.