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What is Gammaked?

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Gammaked ivig and syringe injection. Vial with vaccine against coronavirus on a light blue background. The concept of protection

What is Gammaked?

Gammaked is made from Immunoglobulins (IGs) which are antibodies, naturally made to fight infection. Immune globulin therapy or intravenous immunoglobulin (IVIg) is a therapy that involves the immune globulin intravenous administration 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. Antibodies help protect us against viral and bacterial infections. 

Gammaked serves as an injectable immunoglobulin (IG), utilized as an auxiliary treatment modality 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 the sample, each donor is adequately screened. In addition, every collected sample is also tested to ensure its safety before it is cleared for Gammaked FDA approval.

 

What is Gammaked used for?

Gammaked is indicated for the treatment of the following conditions.

  • Idiopathic Thrombocytopenic Purpura (ITP) in adults and children.
  • Primary Humoral Immunodeficiency (PI) in individuals two years of age and older.
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults.

 

How is Gammaked Administered, and What Dose is used?

Immune globulin 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.

I/V administration only, for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Idiopathic Thrombocytopenic Purpura (ITP) (do not administer subcutaneously)

Indication

DoseInitial fusion 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 fusion rateMaintenance 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 kg1 mg per kg per min8 mg/kg/min Every 3-4 wks

 

How Much Does Gammaked cost? 

Gammaked cost for 10% injectable solution starts from $176 for 10ml on average in most US pharmacies.

The price for different quantities of Gammaked injectable solution is as shown below.

Quantity (ml)Price per unit
10$175.60
25$368.89
50$840.00
100$1670.50
200$3331.51
 

Is Gammaked the Same as Gamunex?

If you have a question about Gammaked vs. Gamunex, it is important to note that these are different brand names, however, the generic drug is the same, i.e., immune globulin. 

Both Gamunex-c and Gammaked IVIgs are similar in most aspects. They are manufactured by Grifols Therapeutics Inc., have the same FDA-approved indications, their pH ranges from 4.0-4.5, and have the same plasma source and halflife (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?

Like any other medical treatment, Gammaked also has its downsides. 

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 your abdomen, chest, arms, or legs
  •         Diarrhea
  •         Muscle spasms or weakness
  •         Muscle pain
  •         Rash
  •         Swelling in ankles or feet
  •         High blood pressure

 

You may also experience 

Side Effects At The Site Of Injection

  • Rash.
  • Bruising
  • Swelling
  • Skin redness
  • Warmth
  • Itchiness
  • Pain.

 

The most commonly occurring side effects related to the route of administration of IVIg and the condition treated include the following. 

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

 

Copay Assistance Program for Gammaked

The Gammaked patient assistance program is open for people who are covered with health insurance. However, the following points must be considered.

  • The insurance should primarily cover the medication they are seeking assistance for.
  • Those individuals having Medicare Part D would be considered on a case-to-case basis.
  • The patient should:

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.

 

Who Can Apply?

Both the patients and healthcare providers can apply by completing the application form online or on the phone.

 

Requirements

The patients should call the respective company for information or let their physician know about what they need. After receiving the request, the healthcare provider’s Gammaked prescribing information recommendation will then be conversed with both the patient and doctor.

Note that you should call your health insurance company for the latest update for the recent qualifying medications because the list is subject to alterations. The prescription for which assistance is sought must directly treat the disease. All the new registrations are done on the phone or electronically. Call your doctor and contact your program for details.

 

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

Patient Access Network Foundation (PAN). RxHope. https://www.rxhope.com/PAP/info/PAPList.aspx?drugid=7514&fieldType=drugid

  1.       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
  2.       Anonymous. Gammaked Prices, Coupons and Patient Assistance Programs. https://www.drugs.com/price-guide/gammaked
  3.       Anonymous. Dosing & Administration. Gammaked. http://www.gammaked.com/healthcare-providers/dosing-administration/