Cuvitru (Intramuscular, Intravenous, Subcutaneous)

Immune globulin injection is used to help 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, 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 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 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 or under the supervision of your doctor.

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 necessary 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). This may increase the risk of developing 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 it has been more than 8 weeks since your last dose. Contact your doctor or nurse immediately if you experience any of these symptoms.

This medicine is made from donated human blood. Although the risk is low, some human blood products have transmitted certain viruses to recipients. Both human donors and donated blood are tested for viruses to minimize this risk. Discuss any concerns about this risk with your doctor.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Inform your doctor right away if you develop 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. Individuals with IgA (an immunoglobulin) deficiency, antibodies against IgA, or a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Contact your doctor immediately if you experience a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or eye sensitivity to light. These could be signs of 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 develop chest pain, difficulty with breathing, fast or noisy breathing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that may produce pink frothy sputum, trouble breathing, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung issue, including transfusion-related acute lung injury (TRALI).

This medicine may increase the risk of blood clots. This is more likely if you have a history of blood clotting issues, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take estrogen-containing medications, or need to remain 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 issues with vision, speech, or walking.

Contact your doctor right away if you notice red or dark brown urine, lower back or side pain, sudden weight gain, swelling in your face, arms, or legs, decreased urine output, or any urination problems after receiving this medicine. These may indicate a serious kidney issue.

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

Make sure any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of certain medical tests.

In deciding to use a drug, the chances of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medication, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific issues that would limit the usefulness of immune globulin injection in children. Some of the products are only used in children who are 2, 3, or 15 years of age and older, and other products are not approved for use in 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 efficacy have not been established for use in chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), or dermatomyositis (DM).

Appropriate studies have not been performed on the relationship of age to the effects of Gamastan® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. Nevertheless, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Appropriate studies have not been performed on the relationship of age to the effects of Gamastan® in the elderly. Safety and efficacy have not been established.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances before using this drug while breastfeeding.

Interactions with Medications

Although certain drugs should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are receiving this drug, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is normally not recommended, but may be required in some cases. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the drugs.

• Pozelimab-bbfg
• Ravulizumab-cwvz

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you inform your physician if you have any other medical issues, especially:

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

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

• Atherosclerosis (hardening of the arteries), history of or
• Blood clotting problems, history of or
• Diabetes or
• Heart attack or stroke, recent 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 cause adverse effects to become worse.

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

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

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

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

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 typically do not need medical attention. These side effects may go away as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Contact your health care professional if any of the following side effects persist or 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 occur in some patients. If you notice any other effects, consult 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.

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.