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What is Gammaked?

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A syringe and a vial of Gammaked

What is Gammaked?

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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Which Health Conditions Benefit From Gammaked?

Gammaked infusions can help treat the following conditions:

 

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

DoseInitial infusion rateMaintenance infusion rate
CIDPLoading dose- 2 g/kg

Maintenance dose – 1 g/kg
2 mg/kg/min8 mg/kg/min (every 3 wks)
ITP2 g/kg1 mg/kg/min8 mg/kg/min
                  

Subcutaneous administration for primary humoral immunodeficiency (PI)

Route of administrationDoseInitial infusion rateMaintenance infusion rate
Subcutaneous (S/C)1.37 x current IV dose in g/IV dose interval in wksAdult-
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 kg1 mg per kg per min8 mg/kg/min Every 3-4 wks

 

Gammaked injection sites

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$175.60
25$368.89
50$840.00
100$1670.50
200$3331.51
 

 

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Is 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 Specialist

 

Gammaked 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.

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REFERENCES:

  1. 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
  2. Patient Access Network Foundation (PAN). RxHope. https://www.rxhope.com/PAP/info/PAPList.aspx?drugid=7514&fieldType=drugid
  3. 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
  4. Anonymous. Gammaked Prices, Coupons and Patient Assistance Programs. https://www.drugs.com/price-guide/gammaked
  5. Anonymous. Dosing & Administration. Gammaked. http://www.gammaked.com/healthcare-providers/dosing-administration/

 

This information is not a substitute for medical advice or treatment. Talk to your doctor or healthcare provider about your medical condition prior to starting any new treatment. AmeriPharma Specialty Care assumes no liability whatsoever for the information provided or for any diagnosis or treatment made as a result, nor is it responsible for the reliability of the content.

AmeriPharma Specialty Care does not operate all the websites/organizations listed here, nor is it responsible for the availability or reliability of their content. These listings do not imply or constitute an endorsement, sponsorship, or recommendation by AmeriPharma Specialty Care.

This webpage may contain references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with AmeriPharma Specialty Care.

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