tesamorelin (Rx)

Brand and Other Names:Egrifta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 1mg/vial (kit containing 2 vials, diluent, syringe, and needles)

HIV-Associated Lipodystrophy

Indicated for reduction of excess abdominal fat in HIB-infected patients with lipodystrophy

2 mg SC once daily

Dosing Considerations

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 antiretroviral therapies in HIV-positive patients taking tesamorelin

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

and tesamorelin

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 hypothalamic-pituitary (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

            Contraindicated

            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

            Centers for Disease Control and Prevention recommend that HIV-infected mothers in the United States not human milk-feed their infants to avoid risking postnatal transmission of HIV-1 infection

            Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, breastfeeding women should be instructed not to human milk-feed

            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: 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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            Administration

            SC Preparation

            Lyophilized powder for reconstitution

            • Reconstitute 2 vials of 1-mg lyophilized powder with supplied diluent
            • Reconstitute first 1-mg vial
              • Reconstitute first 1-mg vial with 2.2 mL of diluent
              • Mix by rolling the vial gently in your hands for 30 seconds
              • Do not shake
            • Reconstitute second 1-mg vial
              • Reconstitute the second 1-mg vial with the entire solution from the first reconstituted vial
              • Mix by rolling the vial gently in your hands for 30 seconds
              • Do not shake
              • Visually inspect for particulate matter and discoloration; solution should appear clear, colorless, and without particulate matter

            SC Administration

            Inject SC in abdomen

            Rotate injection sites to different abdominal areas of the abdomen

            Do not inject into scar tissue, bruises, or the navel

            Storage

            Unopened vial and diluent

            • Unopened vials: Store refrigerated between 2-8°C (36-46°F); protect from light and keep in original box until time of use; do not freeze
            • Diluent, syringes, and needles: Store at controlled room temperature of 20-25°C (68-77°F)

            Reconstituted solution

            • Do not freeze or refrigerate
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.