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.
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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?
Gammaked can be administered through two primary routes, depending on the condition being treated:
IVIG (Intravenous) Administration: The solution is infused directly into the vein, typically in a clinical setting. The conditions treated via IVIG include chronic inflammatory demyelinating polyneuropathy (CIDP), idiopathic thrombocytopenic purpura (ITP), and primary humoral immunodeficiency (PI).
SCIG (subcutaneous) Administration: The solution is injected under the skin, which can often be performed by the patient or a caregiver. SCIG is used primarily for primary humoral immunodeficiency (PI).
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
10 $223.88
50 $1,082.4
100 $2,155.54
200 $4,301.85
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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
In addition to the above, patients should be vigilant for symptoms such as difficulty breathing, skin rashes, sudden weight gain, swelling in the legs, and chest pain. Seek immediate medical attention if these symptoms occur.
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.
FAQs
Can I travel while on Gammaked?
Yes, you can travel while on Gammaked however, you will need to do some careful planning so that you do not run into any issues.
- IVIG: If you receive Gammaked intravenously, you are probably getting an infusion once every 3-4 weeks. You may be able to schedule your infusions before the trip so that you are covered during the duration of your travels.
- SCIG: For those who receive SCIG at home, it may be necessary to pack your medication and supplies so that you can administer it during your travels. Be aware that it is necessary to keep Gammked refrigerated, so additional items such as medical-grade cold packs will be necessary.
Make sure you have a letter from your provider. This letter should include
- Your diagnosis
- Why you need Gammaked
- A list of medications and supplies you are carrying
In addition, research local hospitals or infusion centers at your destination in case you need emergency care or a dose.
For longer trips, your healthcare provider may be able to coordinate infusions at a local clinic.
What if I miss a dose?
If you miss a dose of Gammaked, contact your provider immediately to reschedule. Do not take a double dose to try to make up for the dose you missed.
Are there any dietary or lifestyle changes I need to make while on Gammaked?
No, while you are on Gammaked, there are no specific dietary or lifestyle restrictions. However, be aware that maintaining adequate hydration is crucial, especially before and after Gammaked infusions. Proper fluid intake helps reduce the risk of complications such as blood clots and ensures better kidney function.
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/
