NEWLY APPROVED FDA DRUG

              DRUG NEWS UPDATE

The FDA recently approved some new drugs and here is one of them

Immune globulin (subcutaneous)

Generic Name: immune globulin (subcutaneous) (im MYOON GLOB yoo lin (sub koo TANE ee us))
Brand Name: Hizentra, Vivaglobin

                       

 What is immune globulin?

Immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.
Immune globulin subcutaneous (for injection under the skin) is used to treat primary immunodeficiency (PI).
 Primary immunodeficiency diseases (PI) are a group of more than 300 rare, chronic disorders in which part of the body’s immune system is missing or functions improperly. While not contagious, these diseases are caused by hereditary or genetic defects, and, although some disorders present at birth or in early childhood, the disorders can affect anyone, regardless of age or gender. Some affect a single part of the immune system; others may affect one or more components of the system. And while the diseases may differ, they all share one common feature: each results from a defect in one of the functions of the body’s normal immune system. Because one of the most important functions of the normal immune system is to protect us against infection, patients with PI commonly have an increased susceptibility to infection.The infections may be in the skin, the sinuses, the throat, the ears, the lungs, the brain or spinal cord, or in the urinary or intestinal tracts, and the increased vulnerability to infection may include repeated infections, infections that won’t clear up or unusually severe infections. People with PI live their entire lives more susceptible to infections–enduring recurrent health problems and often developing serious and debilitating illnesses. Fortunately, with proper medical care, many patients live full and independent lives.
Immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about immune globulin?

You should not use immune globulin subcutaneous if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).
This medicine can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, estrogen use, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or if you are using a catheter.
Stop using immune globulin and call your doctor at once if you have:

•    signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;
•    signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood; or
•  signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Immune globulin subcutaneous can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.
Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.
Drink plenty of liquids while you are using this medicine to help improve your blood flow and keep your kidneys working properly.

What should I discuss with my health care provider before using immune globulin?

You should not use this medicine if you have ever had an allergic reaction to an immune globulin, or if you have:

·        immune globulin A (IgA) deficiency with antibody to IgA; or

·        a condition called hyperprolinemia (high level of a certain amino acid in the blood).

Immune globulin subcutaneous can harm your kidneys or cause blood clots. To make sure this medicine is safe for you, tell your doctor if you have:

·        heart disease, blood circulation problems or a blood vessel disorder;

·        a history of stroke or blood clot;

·        if you use estrogens (birth control pills or hormone replacement therapy);

·        kidney disease;

·        diabetes;

·        if you are dehydrated;

·        if you are 65 years or older;

·        if you have been bed-ridden due to severe illness; or

·        if you are using a catheter.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.
FDA pregnancy category C: It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is immune globulin given?

Immune globulin subcutaneous is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.
Immune globulin is usually given once every week. Follow your doctor's dosing instructions. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.
Immune globulin must be given slowly, and the infusion can take about 1 hour to complete. You may need to use up to 4 catheters to inject this medicine into different body areas at the same time. Your care provider will show you the best places on your body to inject the medication. Follow your doctor's instructions.
Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not mix immune globulin with other medications in the same infusion. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
Immune globulin subcutaneous should not be injected into a vein.
Before injecting the medicine, test to make sure the infusion pump needle is not in a vein. To do this, gently pull back on the plunger of the syringe connected to the infusion tube. If blood flows back into the syringe, remove the catheter and tubing and throw them away. Start over with a new catheter and syringe, insert the needle in a new place on your body, and test for blood flow-back again.
Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
While using this medicine, you may need frequent blood tests.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using immune globulin.
Store Hizentra in the original carton at room temperature, away from moisture, heat, and light. Do not freeze.
Store Vivaglobin in its original carton in the refrigerator. Do not freeze. Take the medicine out and allow it to reach room temperature before preparing your dose.
Throw away any immune globulin that has become frozen. Throw away any unused medication after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using immune globulin?

Do not receive a "live" vaccine while using immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:

·        signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

·        signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood;

·        signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

·        signs of a kidney problem--swelling, rapid weight gain, and little or no urinating;

·        liver problems--fast heart rate, tired feeling, dark urine, jaundice (yellowing of the skin or eyes);

·        lung problems--chest pain, trouble breathing, blue lips, pale or blue colored appearance in your fingers or toes; or

·        signs of new infection--high fever, flu symptoms, mouth sores, severe headache, neck stiffness, increased sensitivity to light, nausea and vomiting.

   Common side effects may include:

·        redness, bruising, itching, and swelling where the medicine was injected;

·        nausea, vomiting, diarrhea, bloating, stomach pain;

·        tired feeling, headache, migraine;

·        mild itching or rash;

·        back pain; or

·        pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Immune globulin dosing information

Usual Adult Dose for Primary Immunodeficiency Syndrome:
Begin treatment one week after receiving a regularly scheduled IGIV infusion.
Initial dose: calculated by multiplying the previous IGIV dose by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously; for example, if IGIV was administered every three weeks, divide by 3.

Recommended weekly doses: 100 to 200 mg/kg body weight subcutaneously.
Usual Pediatric Dose for Primary Immunodeficiency Syndrome:
Begin treatment one week after receiving a regularly scheduled IGIV infusion.
>=2 years:
Initial dose: calculated by multiplying the previous IGIV dose by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously; for example, if IGIV was administered every three weeks, divide by 3.

Recommended weekly doses: 100 to 200 mg/kg body weight subcutaneously.

What other drugs will affect immune globulin?

Immune globulin subcutaneous can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).
Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.