Flebogamma 5%

Generic name: Immune Globulin

Usage of Flebogamma 5%

Immune globulin injection is used to prevent infections or make the infection less severe (eg, hepatitis A with not more than 2 weeks of exposure, chickenpox, measles with not more than 6 days of exposure, has not been vaccinated, and has not had measles previously, or rubella) 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, 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 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.

Flebogamma 5% 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

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 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

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, 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.

Before taking Flebogamma 5%

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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 problems 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. However, 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 risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, 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 medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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 medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

How to use Flebogamma 5%

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.

Warnings

It is very important that your doctor check your progress at 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 eye sensitivity to light. 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 with 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 might 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.

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