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Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa A is a dual vial unit containing 100 mg/mL of Immune Globulin Infusion 10% (Human) and 160 U/mL of rHuPH20. Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is available in the following vial volumes: 25 mL, 50 mL, 100 mL, 200 mL and 300 mL.

Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is an immune globulin and is used for the following:
Primary humoral immunodeficiency or PI (a condition that makes you have trouble fighting infections) in people 2 years and older Chronic inflammatory demyelinating polyneuropathy or CIDP (a condition that causes nerve damage) in adults

Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa contains two components. Immunoglobulin G (IgG) — the main component of the medication — is a type of antibody that your immune system makes to help you fight off things that can make you sick (e.g., viruses, bacteria). With PI or CIDP, part of your immune system is either missing or isn’t working like it should. For PI, problems with the immune system can lead to frequent infections. Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is thought to replace IgG and boost your immune system to help prevent infections. For CIDP, a dysfunctional immune system can lead to nerve damage. Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa thought to prevent an overly active immune system from attacking your nerves. Recombinant human hyaluronidase (HY) is a protein that helps your body absorb the medication better when it’s injected under the skin.

Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is given as an injection under the skin of the stomach or thighs using an infusion pump.

PI:

• Your dose depends on your body weight, the IgG levels in your blood, and whether you were previously using another immune globulin therapy
• You’ll start at a low dose, and then ramp up your dose over the first 7 weeks of treatment. You’ll typically infuse the medication once during weeks 1, 2, 4, and 7. Then, you’ll infuse Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa once every 3 to 4 weeks thereafter
• Your provider will adjust your dose based on how well Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is working for you and whether you’re having side effects. Your dose might also differ if you’ve been exposed to measles or if you’re at risk of measles exposure (e.g., traveling to certain places)

CIDP:

• Your Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa dose depends on the dose of your previous intravenous immune globulin (IVIG) therapy
• Your first dose of Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa will be 2 weeks after your last IVIG dose. You’ll start Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa at a low dose and then ramp up your dose over several weeks of treatment (can take up to 9 weeks). Then, you’ll infuse Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa once every 3 to 4 weeks thereafter
• Your provider will adjust your dose based on how well Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is working for you and whether you’re having side effects

Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have any of the following:
Severe allergy to immunoglobulin G, hyaluronidase, or human albumin. Immunoglobulin A deficiency with antibodies against IgA and a history of allergic reaction to immune globulin.

Common side effects of Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa:

• Infusion-site reactions
• Headache
• Feeling tired
• Fever

Serious side effects are rare with Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa. Contact your healthcare provider immediately if you experience any of the following.

• Blood clots: in the lungs (cough, difficulty breathing, chest pain); in the leg (redness, pain, tenderness, swelling of the skin); near the heart (chest pain, pain in the arms or shoulders, pain in the neck or jaw); in the brain (difficulty speaking, numbness on one side of the body, confusion)
• Serious allergic reaction: difficulty breathing, tightness in the throat, hives, fast heartbeat, dizziness, lightheadedness, swelling in the face or tongue
• Brain inflammation: severe headache, neck stiffness, sensitivity to light, painful eye movements
• Kidney problems: tiredness, dry and itchy skin, low appetite, urinating less than usual, foamy or bloody urine, muscle cramps
• Breakdown of red blood cells: tiredness, dizziness, weakness, yellowing of the skin or eyes, dark-colored urine
• Lung problems: severe breathing problems, wheezing or rattling while breathing, chest pain, fever

The following medications may interact with Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa:

• Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, and rubella

Various FDA-approved generic manufacturers

It is not known if Normal Immunoglobulin 10 (Human) With Vorhyaluronidase Alfa can harm your unborn baby. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• Hyqvia