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What is Gammaked?

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What is Gammaked?

Gammaked is made from Immunoglobulins (IGs), which are antibodies that are naturally made by the body 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. 

Gammaked serves as an injectable immunoglobulin (IG), used for treating primary humoral immunodeficiency disorders (PI). In these disorders, patients are deficient in functioning antibodies for fighting infections.

Gammaked is synthesized using plasma that is obtained from FDA-licensed centers in the United States. Before accepting a sample, each donor is adequately screened. In addition, every collected sample is tested to ensure its safety before it is cleared for FDA approval.

 

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What Is Gammaked Used For?

Gammaked is indicated for the treatment of the following conditions:

 

How Is Gammaked Administered, and What Dose Is Used?

Intravenous or subcutaneous administration of Gammaked is performed for different indications. The route for each condition, along with the dose, is tabulated in the Gammaked infusion rate chart below.

IV administration only, for chronic inflammatory demyelinating polyneuropathy (CIDP) and idiopathic thrombocytopenic purpura (ITP) (Do not administer 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 cost of Gammaked for 10% injectable solution starts from $176 for 10ml on average at most U.S. pharmacies.

The price for different quantities of Gammaked injectable solution is shown 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?

Gammaked and Gamunex 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 manufactured by Grifols Therapeutics, Inc., have the same FDA-approved indications, similar pH ranges from 4.0-4.5, and 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.

 

What are the Side Effects of Gammaked?

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)

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

 

Copay Assistance Program for Gammaked

The Gammaked patient assistance program is available for people who are covered by health insurance. However, the following requirements must be met:

  • 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.

Individuals with Medicare Part D will be considered 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 need. After receiving the request, the healthcare provider’s recommendation will then be shared with both the patient and doctor.

You should call your insurance company for the most up-to-date information about qualifying medications because the list is subject to change. 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/
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