somapacitan (Rx)

Brand and Other Names:Sogroya, somapacitan-beco
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection, solution

  • 10mg/1.5mL (6.7mg/mL) prefilled pen

Growth Hormone Deficiency

Indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency

Initial dose: 1.5 mg SC qWeek for either patients who are treatment naïve or those switching from daily growth hormone (somatropin)

Increase weekly dose q2-4weeks by ~0.5-1.5 mg until desired response achieved (based on clinical response and serum [insulinlike growth factor 1] IGF-1 concentrations)

Not to exceed 8 mg qWeek

Dosage Modifications

Decrease dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range

Hepatic impairment

  • Mild (Child-Pugh A): No dose adjustment required
  • Moderate (Child-Pugh B): Initiate with 1 mg SC qWeek and use smaller dose increment increases when titrating; not to exceed 4 mg qWeek
  • Severe (Child-Pugh C): Not recommended

Renal impairment

  • In general, systemic exposure tends to increase with decreasing eGFR
  • 0.08 mg/kg dose at steady-state resulted in higher exposures in patients with renal impairment, which was most pronounced for patients with severe renal impairment and those requiring hemodialysis
  • Higher IGF-1 levels were also observed with moderate and severe renal impairment and in patients requiring hemodialysis

Women receiving oral estrogen

  • Initiate with 2 mg SC qWeek; titrate based on clinical response and serum IGF-1 concentrations

Dosing Considerations

Draw IGF-1 samples 3-4 days after the prior dose

Safety and efficacy not established

Dosage Forms & Strengths

injection, solution

10mg/1.5mL (6.7mg/mL) prefilled pen

Growth Hormone Deficiency

Indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency

Initial dose, age ≥65 years: 1 mg SC qWeek for either patients who are treatment naïve or those switching from daily growth hormone (somatropin)

Increase weekly dose q2-4weeks by small increments that are recommended for younger adults until desired response achieved (based on clinical response and serum IGF-1 concentrations)

Not to exceed 8 mg qWeek

Dosage Modifications

Decrease dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate: Initiate with 1 mg SC qWeek and use smaller dose increment increases when titrating; not to exceed 4 mg qWeek
  • Severe: Not recommended

Renal impairment

  • In general, systemic exposure tends to increase with decreasing eGFR
  • 0.08 mg/kg dose at steady-state resulted in higher exposures in patients with renal impairment, which was most pronounced for patients with severe renal impairment and those requiring hemodialysis
  • Higher IGF-1 levels were also observed with moderate and severe renal impairment and in patients requiring hemodialysis

Women receiving oral estrogen

  • Initiate with 2 mg SC qWeek; titrate based on clinical response and serum IGF-1 concentrations

Dosing Considerations

Draw IGF-1 samples 3-4 days after the prior dose

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Interactions

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            Adverse Effects

            1-10%

            Back pain (10%)

            Arthralgia (6.7%)

            Dyspepsia (5%)

            Sleep disorder (4.2%)

            Dizziness (4.2%)

            Tonsillitis (3.3%)

            Peripheral edema (3.3%)

            Vomiting (3.3%)

            Adrenal insufficiency (3.3%)

            Hypertension (3.3%)

            Increased CPK (3.3%)

            Weight increased (3.3%)

            Anemia (2.5%)

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            Warnings

            Contraindications

            Acute critical illness after open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure; risk of increased mortality with pharmacologic doses of somapacitan

            Active malignancy

            Hypersensitivity to drug or any of its excipients; systemic hypersensitivity reactions reported with other growth hormone products

            Active proliferative or severe nonproliferative diabetic retinopathy

            Cautions

            Increased mortality reported after treatment with pharmacologic amounts of growth hormone products in patients with acute critical illness owing to complications following open heart surgery, abdominal surgery, and multiple accidental trauma, as well as those with acute respiratory failure

            May decrease insulin sensitivity, particularly at higher doses; new-onset type 2 diabetes mellitus reported in patients taking growth hormone products; patients with undiagnosed prediabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic; monitor glucose levels periodically in all patients receiving therapy, especially with prediabetes/diabetes or risk factors for diabetes mellitus (eg, obesity, family history)

            Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting reported with growth hormone products; symptoms usually occur within first 8 weeks of initiating; perform funduscopic examination before initiating and periodically thereafter; if papilledema observed by funduscopy during treatment, stop therapy; if intracranial hypertension diagnosed, may restart treatment at a lower dose after intracranial hypertension-associated signs and symptoms have resolved

            Serious systemic hypersensitivity reactions, including anaphylactic reactions and angioedema, reported postmarketing with growth hormone products

            Fluid retention may occur, manifested by edema and nerve compression syndromes, including carpal tunnel syndrome/paresthesia; these symptoms are usually transient and dose dependent

            Patients receiving growth hormone therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism; additionally, those treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan

            Undiagnosed/untreated hypothyroidism may prevent an optimal response; in patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy; periodically monitor thyroid function

            Pancreatitis reported; consider this in patients who develop persistent severe abdominal pain

            SC administration at the same site over a long time may cause tissue lipohypertrophy or lipoatrophy; rotate injection sites

            Increased serum levels of inorganic phosphorous, alkaline phosphatase, and parathyroid hormone may occur

            Malignancies

            • Active malignancy
              • Increased risk of malignancy progression with growth hormone treatment in patients with active malignancy
              • Any preexisting malignancy should be inactive, and its treatment complete before initiating somapacitan
              • Discontinue drug if there is evidence of recurrent activity
            • New skin malignancy
              • Potential risk of malignant changes of preexisting nevi
              • Monitor carefully for increased growth, or potential malignant changes, of preexisting nevi
              • Advise patients to report changes in skin pigmentation or changes in nevi appearance

            Drug interaction overview

            • Glucocorticoids
              • Patients treated with glucocorticoid replacement for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan
              • Microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1 (11βHSD-1) required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue
              • Growth hormone inhibits 11βHSD-1; consequently, individuals with untreated growth hormone deficiency have relative increases in 11βHSD-1 and serum cortisol
              • Initiating somapacitan may inhibit 11βHSD-1 and reduce serum cortisol concentrations
            • CYP450 substrates
              • Limited data suggest growth hormone increases CYP450-mediated clearance
              • Monitor CYP450 substrates
            • Oral estrogen
              • Oral estrogens may reduce serum IGF-1 response to somapacitan
              • Higher estrogen dosage may be required
            • Insulin and/or other hypoglycemic agents
              • Somapacitan may decrease insulin sensitivity, particularly at higher doses
              • Insulin or other hypoglycemia agents may require dose adjustment
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            Pregnancy & Lactation

            Pregnancy

            Data are not available regarding use in pregnant women

            Published studies with short-acting recombinant growth hormone (rhGH) use in pregnant women over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal data

            • SC administration was not teratogenic in rats or rabbits during organogenesis at doses ~12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week
            • No adverse developmental outcomes were observed in a prenatal and postnatal development study with administration to pregnant rats from organogenesis through lactation at ~275 times the clinical exposure at the MRHD

            Lactation

            Data are not available regarding presence in human milk, effects on breastfed infant, or effects on milk production

            Somapacitan-related material was secreted into milk of lactating rats; when a substance is present in animal milk, it is likely to be present in human milk.

            Available published data describing administration of short-acting rhGH to lactating women for 7 days reported that short-acting rhGH did not increase the normal breastmilk concentration of growth hormone and no adverse effects were reported in breastfed infants

            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

            Long-acting human growth hormone derivative designed to bind to circulating albumin; it is based on a protein technology commonly used to formulate long-acting insulins and glucagonlike peptide-1

            Binds to a dimeric growth hormone receptor in the cell membrane of target cells, resulting in intracellular signal transduction and a host of pharmacodynamic effects

            Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor 1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan

            Absorption

            Peak plasma concentration: 4-24 hr

            Steady-state achieved following 1-2 weeks of once weekly dosing

            Distribution

            Protein bound: >99%

            Vd: ~14.6 L

            Metabolism

            Metabolized via proteolytic cleavage of the linker sequence between the peptide backbone and albumin binder sidechain

            Elimination

            Half-life: ~2-3 days

            Excretion: Urine ~81%; feces ~13%

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            Administration

            SC Preparation

            Write date of first use in space provided on carton

            Always remove and safely discard needle after each injection and store prefilled pen without an injection needle attached

            Always use a new needle for each injection to prevent contamination

            Visually inspect for particulate matter and discoloration; solution should appear clear to slightly opalescent and colorless to slightly yellow

            Do not use if solution is cloudy or contains particulate matter

            SC Administration

            Administer by SC injection to abdomen or thigh; regularly rotate injection sites to avoid lipohypertrophy

            Prefilled pen dials in 0.05-mg increments and delivers doses from 0.05-4 mg

            Missed dose

            • Administer missed dose as soon as possible, but not >3 days after the missed dose (72 hr)
            • If >3 days have passed since missed dose, skip the dose and administer the next dose on the regular dosing day

            Storage

            Unused pen

            • Refrigerate at 36-46ºF (2-8ºC) with cap on and in original carton to protect from light
            • Do not freeze; do not use if it has been frozen
            • May store at room temperature (up to 77°F [25°C]) for up to 72 hr; discard prefilled pen if kept above 86ºF (30ºC)
            • Avoid direct or excessive heat
            • Avoid sunlight

            After first use

            • Refrigerate at 36-46ºF (2-8ºC) with cap on for up to 6 weeks and in original carton to protect from light
            • Do not freeze; do not use if it has been frozen
            • May store at room temperature (up to 77°F [25°C]) for up to 72 hr; discard prefilled pen if kept above 86ºF (30ºC)
            • Avoid direct or excessive heat
            • Avoid sunlight
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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.
            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.
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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.