Gammaked is made from immunoglobulins (IGs). These are antibodies that the body naturally produces to fight infections. Immune globulin therapy, or intravenous immunoglobulin (IVIG), is a therapy that involves the intravenous administration of immune globulin for the treatment of various infectious conditions in adults and children.
What Is Gammaked?
Gammaked is a sterile, decontaminated, ready-to-use 10% solution of human immunoglobulins. It is extracted from human plasma and comprises antibodies, which help protect us against viral and bacterial infections.
It is an injectable immunoglobulin (IG) for treating primary humoral immunodeficiency disorders (PI). In these disorders, patients are deficient in functioning antibodies for fighting infections.
This solution is synthesized using plasma from FDA-licensed centers in the United States. Before accepting a sample, the centers adequately screen each donor. In addition, they test each product to ensure its safety before sending it for FDA approval.
Get IVIG Copay Assistance
Speak to a SpecialistWhich Health Conditions Benefit From Gammaked?
Gammaked infusions can help treat the following conditions:
- Idiopathic thrombocytopenic purpura (ITP) in adults and children.
- Primary humoral immunodeficiency (PI) in individuals two years and older.
- Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
How Is Gammaked Administered, and What Dose Is Used?
Intravenous or subcutaneous administration of the solution is performed for different indications. You can see the route and dose for each condition in the infusion rate chart below.
IV administration only for chronic inflammatory demyelinating polyneuropathy (CIDP) and idiopathic thrombocytopenic purpura (ITP) (Do not administer Gammaked subcutaneously).
| Indication | Dose | Initial infusion rate | Maintenance infusion rate |
|---|---|---|---|
| CIDP | Loading dose- 2 g/kg Maintenance dose – 1 g/kg | 2 mg/kg/min | 8 mg/kg/min (every 3 wks) |
| ITP | 2 g/kg | 1 mg/kg/min | 8 mg/kg/min |
Subcutaneous administration for primary humoral immunodeficiency (PI)
| Route of administration | Dose | Initial infusion rate | Maintenance infusion rate |
|---|---|---|---|
| Subcutaneous (S/C) | 1.37 x current IV dose in g/IV dose interval in wks | Adult- 20 ml/hr/site, Pediatric- 10 ml/hr/site (< 25 kg) 15 ml/hr/site (≥ 25 kg) | Adult- 20 ml/hr/site Pediatric- 10 ml/hr/site (< 25 kg) 20 ml/hr/site (≤ 25 kg) Weekly |
| Intravenous (I/V) | 300 to 600 mg per kg | 1 mg per kg per min | 8 mg/kg/min Every 3-4 wks |
How Much Does Gammaked Cost?
The average cost of Gammaked infusion for 10% injectable solution starts from $176 for 10ml at most U.S. pharmacies.
You can see the price for different quantities of the injectable solution below:
Quantity (ml) Price per unit
10 $175.61
25 $368.89
50 $840.00
100 $1670.50
200 $3331.51
Get Your IVIG Dose
At-Home InfusionIs Gammaked the Same as Gamunex?
They are different brand names. However, the generic drug is the same (i.e., immune globulin).
Gamunex-C and Gammaked IVIG are similar in most aspects. They are made by Grifols Therapeutics, Inc., have the same FDA-approved indications, similar pH ranges from 4.0-4.5, and have the same plasma source and half-life (35 hours).
However, Gamunex-C has a slightly higher IgA content of 51 ± 1.4 mcg/ml as opposed to 47 ± 13 mcg/ml for Gammaked infusions.
What are the Side Effects of Gammaked?
Side Effects
- Headache
- Chills and fever
- Weakness
- Lethargy
- Dizziness
- Ear pain
- Cough
- Asthma
- Inflammation of the throat and nasal passages
- Painful soreness in the mouth and throat with white patches and red areas
- Nausea
- Vomiting
- Pain in the abdomen, chest, arms, or legs
- Diarrhea
- Muscle spasms or weakness
- Muscle pain
- Rash
- Swelling in ankles or feet
- High blood pressure
Side Effects at the Injection Site
- Rash
- Bruising
- Swelling
- Skin redness
- Warmth
- Itchiness
- Pain
The most common side effects by the route of administration and condition treated are listed below.
Adverse Reactions (Found to Occur in 5% of Patients Receiving Gammaked Infusions)
Primary Humoral Immunodeficiency (PI)
Intravenous:
- Increased cough
- Headache
- Rhinitis
- Pharyngitis
- Asthma
- Nausea
- Fever
- Sinusitis
- Diarrhea
Subcutaneous:
- Headache
- Fatigue
- Local infusion site reactions
- Upper respiratory tract infection
- Diarrhea
- Arthralgia
- Nausea
- Bronchitis
- Sinusitis
- Depression
- Erythema
- Allergic dermatitis
- Myalgia
- Migraine
- Pyrexia
- Viral infection
Idiopathic Thrombocytopenic Purpura (ITP)
- Nausea
- Vomiting
- Ecchymosis
- Headache
- Fever
- Rash
- Back pain
- Abdominal pain
- Dyspepsia
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Nausea
- Pyrexia
- Headache
- Hypertension
- Rash
- Chills
- Asthenia
- Arthralgia
Get IVIG Copay Assistance
Speak to a SpecialistGammaked Copay Assistance Program
The Gammaked patient assistance program is available for people with health insurance. However, they must meet the following requirements:
- The insurance must cover the medication for which the patient is seeking assistance.
- The patient must:
- Be at or lower than 400% to 500% of the federal poverty level.
- Have a therapeutically proper diagnosis or condition.
- Be located in and receive treatment in the United States.
The program will consider individuals with Medicare Part D on a case-by-case basis.
Who Can Apply?
Both the patients and healthcare providers can apply by completing the application form online or on the phone.
Requirements
Patients should call for information or let their physician know about their needs. After receiving the request, the healthcare providers will share their recommendations with the patient and the doctor.
You should call your insurance company for the most up-to-date information about qualifying medications because the list is subject to change, and Gammaked may not be on it. The prescription for which you are seeking assistance must directly treat the disease. All new registrations are done on the phone or electronically.
REFERENCES:
- Seigel J. immune Globulins: therapeutic, pharmaceutical, cost, and administration considerations. Pharmacy practice news. 2015. https://www.gbs-cidp.org/wp-content/uploads/2015/10/Immune_globulins_ppnse_15_WM.pdf
- Patient Access Network Foundation (PAN). RxHope. https://www.rxhope.com/PAP/info/PAPList.aspx?drugid=7514&fieldType=drugid
- Anonymous. Immune globulin (intravenous and subcutaneous) (Gammagard Liquid, Gammaked, Gamunex-C). emedicine health. https://www.emedicinehealth.com/drug-immune_globulin_intravenous_and_subcutaneous/article_em.htm
- Anonymous. Gammaked Prices, Coupons and Patient Assistance Programs. https://www.drugs.com/price-guide/gammaked
- Anonymous. Dosing & Administration. Gammaked. http://www.gammaked.com/healthcare-providers/dosing-administration/
