Gammaked Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-use vials—1
Manufacturer
Generic Availability
Mechanism of Action
Gammaked Indications
Indications
Gammaked Dosage and Administration
Adults and Children
Gammaked Contraindications
Contraindications
Gammaked Boxed Warnings
Boxed Warning
Gammaked Warnings/Precautions
Warnings/Precautions
Gammaked Pharmacokinetics
See Literature
Gammaked Interactions
Interactions
Gammaked Adverse Reactions
Adverse Reactions
Gammaked Clinical Trials
See Literature
Gammaked Note
Not Applicable
Gammaked Patient Counseling
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Gammaked Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-use vials—1
Manufacturer
Generic Availability
Mechanism of Action
Gammaked Indications
Indications
Gammaked Dosage and Administration
Adults and Children
See full labeling. Individualize. Primary immunodeficiency (PI): <2yrs: not established. ≥2yrs: IV infusion: 300–600mg/kg every 3–4 weeks. Initial infusion rate: 1mg/kg/min for first 30mins; may gradually increase to max 8mg/kg/min if tolerated. Risk of measles exposure with routine dose of <400mg/kg every 3–4 weeks: give at least 400mg/kg dose just prior to expected exposure; if exposed, give 400mg/kg dose as soon as possible. SC infusion: start 1 week after last IGIV infusion. Give by using an infusion pump into abdomen, thigh, upper arm, and/or lateral hip areas. May use up to 6 (children) or 8 (adults) infusion sites (at least 2 inches apart) simultaneously. Obtain serum IgG trough level to guide subsequent dose adjustments. Initial weekly dose = (1.37 x previous IGIV dose [in grams])/number of weeks between IGIV doses. Infusion rate: adults: 20mL/hr/site; children/adolescents (if <25kg): 10mL/hr/site; (if ≥25kg): initially 15mL/hr/site, then increase up to 20mL/hr/site. Dose adjustments: see full labeling. CIDP: children: not established. Give as IV infusion only. Adults: initially 2g/kg loading dose divided over 2–4 consecutive days. May be administered as a maintenance infusion: 1g/kg given over 1 day or divided in 2 doses of 0.5g/kg given on 2 consecutive days, every 3 weeks. Initial infusion rate: 2mg/kg/min; may increase to max 8mg/kg/min if tolerated. For PI (IV regimen), CIDP: if risk for renal dysfunction/failure or thrombosis, give at the minimum infusion rate practicable.
Gammaked Contraindications
Contraindications
Gammaked Boxed Warnings
Boxed Warning
Gammaked Warnings/Precautions
Warnings/Precautions
Gammaked Pharmacokinetics
See Literature
Gammaked Interactions
Interactions
Gammaked Adverse Reactions
Adverse Reactions
Gammaked Clinical Trials
See Literature
Gammaked Note
Not Applicable
Gammaked Patient Counseling
See Literature