• Treatment of acromegaly in patients who do not respond to or are not candidates for surgery, radiation, or other medical therapies.

Contraindicated in:

• Hypersensitivity
• Latex allergy (vial stopper contains latex).

Use Cautiously in:

• Diabetes mellitus
• Patients with growth hormone-secreting tumors
• OB: Safety not established in pregnancy
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

CV: hypertension, peripheral edema.

Derm: lipohypertrophy.

Endo: ↑ glucose tolerance, growth hormone deficiency.

GI: ↑ liver enzymes.

GU: ↑ fertility.

MS: back pain.

Misc: hypersensitivity reactions (including anaphylaxis and angioedema).

Drug-Drug:

• Patients receiving opioid analgesics often require ↑ doses of pegvisomant to normalize IGF-1.

• Lyophilized powder for injection: 10 mg/vial; 15 mg/vial; 20 mg/vial; 25 mg/vial; 30 mg/vial;

• SC (Adults): Loading dose: 40 mg; maintenance dose: 10 mg daily, further adjustments in increments/decrements of 5 mg are made based on monitoring of IGF-1 levels (not to exceed 30 mg/day).

Somavert

• Binds to growth hormone (GH) receptor sites on cell surfaces, blocking the effects of endogenous growth hormone.
• Bound to polyethylene glycol (PEG) to reduce clearance and increase duration of action.

• Decreased manifestations of acromegaly and normalized insulin-like growth factor-1 (IGF-1) levels.

Therapeutic Classification: hormones

Pharmacologic Classification: growth hormones

Absorption: 57% absorbed following SUBQ administration.

Distribution: Does not distribute extensively into tissues.

Metabolism/Excretion: Unknown.

Half-life: 6 days.

(effects on IGF-1)

• Instruct patient on the correct technique for administering pegvisomant. Review patient information sheet, preparation of dose, administration sites and technique, and disposal of equipment into a puncture-resistant container. Inform patient that further questions may be answered by their health care professional or by calling (800)-645-1280.
• Instruct patient that missed doses should be omitted; return to schedule the next day. Do not inject a double dose to make up for a forgotten injection.
• Instruct patient to inform their health care professional if they have diabetes or liver problems, or if they take opioid medications.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until effect of the drug is known.
• Advise patient to consult health care professional before taking other Rx or OTC medications, or herbal products.
• Instruct patient to notify health care professional promptly if skin or whites of the eyes turn yellow (jaundice), urine turn dark, stools turn light in color, decreased appetite, nausea, unexplained tiredness, or abdominal pain occur.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize the need for frequent lab test to adjust dose and monitor for adverse effects.

peg-VIS-o-mant

NDC Code^*

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5176- SOMAVERT
    • 0009-5176-01- 1 KIT in 1 PACKAGE (0009-5176-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-01) * 1 mL in 1 VIAL, SINGLE-DOSE

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5176- SOMAVERT
    • 0009-5176-02- 1 KIT in 1 PACKAGE (0009-5176-02) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-01) * 1 mL in 1 VIAL, SINGLE-DOSE

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5178- SOMAVERT
    • 0009-5178-01- 1 KIT in 1 PACKAGE (0009-5178-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5177-01) * 1 mL in 1 VIAL, SINGLE-DOSE

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5178- SOMAVERT
    • 0009-5178-02- 1 KIT in 1 PACKAGE (0009-5178-02) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5177-01) * 1 mL in 1 VIAL, SINGLE-DOSE

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5180- SOMAVERT
    • 0009-5180-01- 1 KIT in 1 PACKAGE (0009-5180-01) * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5179-01)

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5180- SOMAVERT
    • 0009-5180-02- 1 KIT in 1 PACKAGE (0009-5180-02) * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5179-01)

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5199- SOMAVERT
    • 0009-5199-01- 1 KIT in 1 PACKAGE (0009-5199-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5201-04) * 1 mL in 1 VIAL, SINGLE-DOSE

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-5200- SOMAVERT
    • 0009-5200-01- 1 KIT in 1 PACKAGE (0009-5200-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5376-04) * 1 mL in 1 VIAL, SINGLE-DOSE

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-7166- SOMAVERT
    • 0009-7166-01- 1 KIT in 1 CARTON (0009-7166-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5175-02) * 1 mL in 1 SYRINGE (0009-5936-01)

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-7168- SOMAVERT
    • 0009-7168-01- 1 KIT in 1 CARTON (0009-7168-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5177-02) * 1 mL in 1 SYRINGE (0009-5936-01)

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-7188- SOMAVERT
    • 0009-7188-01- 1 KIT in 1 CARTON (0009-7188-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5179-02) * 1 mL in 1 SYRINGE (0009-5936-01)

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-7199- SOMAVERT
    • 0009-7199-01- 1 KIT in 1 CARTON (0009-7199-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5201-02) * 1 mL in 1 SYRINGE (0009-5936-01)

• 0009- Pharmacia and Upjohn Company LLC
  • 0009-7200- SOMAVERT
    • 0009-7200-01- 1 KIT in 1 CARTON (0009-7200-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5376-04) * 1 mL in 1 SYRINGE (0009-5936-01)