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tesamorelin (Rx)Brand and Other Names:Egrifta

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, subcutaneous

  • 2mg/vial (1mg/mL solution after reconstituted)
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HIV-Associated Lipodystrophy

2 mg SC qDay, preferably once daily

Inject into abdomen (avoid the navel or any scar tissue) and rotate injection site daily

Limitations of use

Long-term cardiovascular benefit and safety not studied

Not indicated for weight loss management (weight neutral effect)

There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking tesamorelin

Administration

Reconstitute lyophilized powder with supplied 2.1 mL of diluent

Mix by rolling the vial gently in your hands for 30 seconds

Do not shake

Storage

Unopened vial: Store refrigerated between 2-8°C (36-46°F) until the expiration date or below 25°C (77°F) for 3 months or until the expiration date, whichever occurs first

Protect from light

Do not freeze

Store reconstitution diluent (Sterile Water for Injection, USP), syringes, and needles at controlled room temperature of 20-25°C (68-77°F)

Do not freeze or refrigerate the reconstituted solution

Safety and efficacy not established

Should not be used in children with open epiphyses, among whom excess GH and IGF-I may result in linear growth acceleration and excessive growth

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Interactions

Interaction Checker

tesamorelin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Arthralgia (13.3%)

            1-10%

            Injection site reactions (up to 8.5%)

            Extremity pain (6.1%)

            Myalgia (5.5%)

            Paresthesia (4.8%)

            Nausea (4.4%)

            Hypoesthesia (4.2%)

            Rash (3.7%)

            Vomiting (2.6%)

            Pruritus (2.4%)

            Depression (2%)

            Dyspepsia (1.7%)

            Musculoskeletal pain and stiffness (1.7-1.8%)

            Increased CPK (1.5%)

            Carpal tunnel syndrome (1.5%)

            Joint stiffness/swelling (1.1-1.5%)

            Hypertension (1.3%)

            Muscle spasms (1.1%)

            < 1%

            Anemia

            Abdominal abscess

            Cerebellar syndrome

            Mental status changes

            Sepsis

            Trigeminal neuralgia

            Viral bronchitis

            Upper respiratory tract infection

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            Warnings

            Contraindications

            Hypersensitivity to tesamorelin or mannitol

            Disruption of HP axis caused by hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma

            Active malignancy

            Pregnancy

            Cautions

            Caution with history of nonmalignant neoplasms; preexisting malignancy should be inactive and treatment complete prior to initiating therapy

            If hypersensitivity suspected, discontinue and provide immediate medical attention

            Consider discontinuing with persistent elevations of IGF-I levels (eg, >3 SDS), particularly if efficacy response is not robust

            Fluid retention may occur and may include edema, arthralgia, and carpal tunnel syndrome

            Increased mortality with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure following treatment with pharmacologic amounts of growth hormone

            May modulate CYP450-mediated antipyrine clearance

            Not for use in children when epiphyses open because may cause excessive growth

            Inhibits 11-beta-hydroxysteroid dehydrogenase type-1, a microsomal enzyme required for conversion of cortisone and prednisone to their active metabolites

            Injections site reactions including irritation, erythema, pain, and bruising may occur; rotate site of injection to different areas of abdomen to reduce incidence of injection site reactions

            May increase risk of development of diabetes due to glucose intolerance; evaluate glucose status prior to and during therapy

            Not indicated for weight loss management

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            Pregnancy & Lactation

            Pregnancy Category: X

            During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes; modifying this physiologic change offers no known benefit and could result in fetal harm

            Administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at 2-4 times clinical dose

            Lactation: Unknown whether distributed in breast milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Growth hormone releasing factor (GRF) analog; stimulates growth hormone production and increases serum IGF-I; elicits anabolic and lipolytic actions;

            Pharmacokinetics

            Half-Life: 38 minutes

            Absorption: <4%

            Peak Plasma Time: 9 min

            Peak Plasma Concentration (Cmax): 2822.3 pg/mL

            Vd: 10.5 L/kg (HIV infected patients); 9.4 L/kg (healthy adults)

            Bioavailability: <4% (healthy adults)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
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