SOMAVERT® WITH DILUENT VIAL Principal Display Panel (pegvisomant)

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label

1 mL SINGLE-DOSE
NDC 0009-5936-01

Sterile Water for Injection, USP

For reconstitution of SOMAVERT®
Contains no antimicrobial or other
added substance. Sterile, nonpyrogenic.

Manufactured by
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc
New York, NY 10017
U.S. License No. 1216

LOT/EXP

Rx only

PAA171515

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 10 mg Vial Label

Pfizer
NDC 0009-5175-02

Somavert®
(pegvisomant) for injection

10 mg/vial

For Subcutaneous Use Only

One Single-Dose Vial
Discard unused portion.

Rx only

PAA169838

PRINCIPAL DISPLAY PANEL - 10 mg Vial Label

PRINCIPAL DISPLAY PANEL - Kit Carton - 7166-01

NDC 0009-7166-01

Pfizer

Somavert®
(pegvisomant) for injection

10 mg/vial

For Subcutaneous Injection Only

One Single-Dose Vial
Discard unused portion.
Contents: One Somavert single-dose vial, one diluent prefilled
syringe containing 1 mL Sterile Water for Injection, USP and
one 27 gauge ½ inch safety needle.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7166-01

PRINCIPAL DISPLAY PANEL - 10 mg Vial Carton

Pfizer

Somavert®
(pegvisomant) for injection

NDC 0009-5175-10

10 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of intermediate carton:
Ten single-dose vials of Somavert

Rx only

PRINCIPAL DISPLAY PANEL - 10 mg Vial Carton

PRINCIPAL DISPLAY PANEL - Kit Carton - 7166-30

NDC 0009-7166-30

Pfizer
Somavert®
(pegvisomant) for injection

10 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.
Contents of outer carton:
Three intermediate cartons (each containing ten single-dose vials of
Somavert), thirty diluent prefilled syringes containing 1 mL Sterile
Water for Injection, USP and thirty 27 gauge ½ inch safety needles.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7166-30

PRINCIPAL DISPLAY PANEL - 15 mg Vial Label

Pfizer
NDC 0009-5177-02

Somavert®
(pegvisomant) for injection

15 mg/vial

For Subcutaneous Use Only

One Single-Dose Vial
Discard unused portion.

Rx only

PAA169992

PRINCIPAL DISPLAY PANEL - 15 mg Vial Label

PRINCIPAL DISPLAY PANEL - Kit Carton - 7168-01

Pfizer

Somavert®
(pegvisomant) for injection

NDC 0009-7168-01

15 mg/vial

For Subcutaneous Injection Only

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7168-01

PRINCIPAL DISPLAY PANEL - 15 mg Vial Carton

Pfizer

Somavert®
(pegvisomant) for injection

NDC 0009-5177-10

15 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of intermediate carton:
Ten single-dose vials of Somavert

Rx only

PRINCIPAL DISPLAY PANEL - 15 mg Vial Carton

PRINCIPAL DISPLAY PANEL - Kit Carton - 7168-30

NDC 0009-7168-30

Pfizer

Somavert®
(pegvisomant) for injection

15 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.
Contents of outer carton:
Three intermediate cartons (each containing ten single-dose
vials of Somavert), thirty diluent prefilled syringes containing
1 mL Sterile Water for Injection, USP and thirty 27 gauge ½
inch safety needles.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7168-30

PRINCIPAL DISPLAY PANEL - 20 mg Vial Label

Pfizer
NDC 0009-5179-02

Somavert®
(pegvisomant) for injection

20 mg/vial

For Subcutaneous Use Only

One Single-Dose Vial
Discard unused portion.

Rx only

PAA169996

PRINCIPAL DISPLAY PANEL - 20 mg Vial Label

PRINCIPAL DISPLAY PANEL - Kit Carton - 7188-01

Pfizer

Somavert®
(pegvisomant) for injection

NDC 0009-7188-01

20 mg/vial

For Subcutaneous Injection Only

One Single-Dose Vial
Discard unused portion.

Contents: One Somavert single-dose vial, one diluent prefilled
syringe containing 1 mL Sterile Water for Injection, USP and
one 27 gauge ½ inch safety needle.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7188-01

PRINCIPAL DISPLAY PANEL - 20 mg Vial Carton

Pfizer

Somavert®
(pegvisomant) for injection

NDC 0009-5179-10

20 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of intermediate carton:
Ten single-dose vials of Somavert

Rx only

PRINCIPAL DISPLAY PANEL - 20 mg Vial Carton

PRINCIPAL DISPLAY PANEL - Kit Carton - 7188-30

NDC 0009-7188-30

Pfizer

Somavert®
(pegvisomant) for injection

20 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of outer carton:
Three intermediate cartons (each containing ten single-dose
vials of Somavert), thirty diluent prefilled syringes containing 1 mL
Sterile Water for Injection, USP and thirty 27 gauge ½ inch
safety needles.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7188-30

PRINCIPAL DISPLAY PANEL - 25 mg Vial Label

Pfizer
NDC 0009-5201-04

Somavert®
(pegvisomant) for injection

25 mg/vial

For Subcutaneous Use Only

One Single-Dose Vial
Discard unused portion.

Rx only

PAA170000

PRINCIPAL DISPLAY PANEL - 25 mg Vial Label

PRINCIPAL DISPLAY PANEL - Kit Carton - 7199-01

NDC 0009-7199-01

Pfizer

Somavert®
(pegvisomant) for injection

25 mg/vial

For Subcutaneous Injection Only

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7199-01

PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton

NDC 0009-5201-10

Pfizer

Somavert®
(pegvisomant) for injection

25 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of intermediate carton:
Ten single-dose vials of Somavert

Rx only

PRINCIPAL DISPLAY PANEL - 25 mg Vial Carton

PRINCIPAL DISPLAY PANEL - Kit Carton - 7199-30

NDC 0009-7199-30

Pfizer

Somavert®
(pegvisomant) for injection

25 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of outer carton:
Three intermediate cartons (each containing ten single-dose
vials of Somavert), thirty diluent prefilled syringes containing
1 mL Sterile Water for Injection, USP and thirty 27 gauge ½ inch
safety needles.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7199-30

PRINCIPAL DISPLAY PANEL - 30 mg Vial Label

Pfizer

NDC 0009-5376-04

Somavert®
(pegvisomant) for injection

30 mg/vial

For Subcutaneous Use Only

One Single-Dose Vial
Discard unused portion.

Rx only

PAA171451

PRINCIPAL DISPLAY PANEL - 30 mg Vial Label

PRINCIPAL DISPLAY PANEL - Kit Carton - 7200-01

NDC 0009-7200-01

Pfizer

Somavert®
(pegvisomant) for injection

30 mg/vial

For Subcutaneous Injection Only

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7200-01

PRINCIPAL DISPLAY PANEL - 30 mg Vial Carton

Pfizer

Somavert®
(pegvisomant) for injection

NDC 0009-5376-10

30 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.

Contents of intermediate carton:
Ten single-dose vials of Somavert

Rx only

PRINCIPAL DISPLAY PANEL - 30 mg Vial Carton

PRINCIPAL DISPLAY PANEL - Kit Carton - 7200-30

NDC 0009-7200-30

Pfizer

Somavert®
(pegvisomant) for injection

30 mg/vial

For Subcutaneous Injection Only

Single-Dose Vials
Discard unused portion.
Contents of outer carton:
Three intermediate cartons (each containing ten single-dose
vials of Somavert), thirty diluent prefilled syringes containing 1 mL
Sterile Water for Injection, USP and thirty 27 gauge ½ inch safety
needles.

Rx only

PRINCIPAL DISPLAY PANEL - Kit Carton - 7200-30

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

SOMAVERT® WITH DILUENT VIAL Quick Finder

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To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
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Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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1 INDICATIONS AND USAGE

SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of...

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2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

The recommended loading dose of SOMAVERT is 40 mg given subcutaneously, under healthcare provider supervision....

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3 DOSAGE FORMS AND STRENGTHS

For injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg white lyophilized powder in a single-dose vial for reconstitution supplied with a prefilled syringe containing 1 mL of diluent (Sterile Water...

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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Hypoglycemia Associated With GH Lowering in Patients With Diabetes Mellitus

GH opposes the effects of insulin on carbohydrate...

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6 ADVERSE REACTIONS

Clinically significant adverse reactions that appear in other section of the labeling include:

•: Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus...

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7 DRUG INTERACTIONS

7.1 Insulin and/or Oral Hypoglycemic Agents

After initiation of SOMAVERT, patients with acromegaly and diabetes mellitus treated with insulin and/...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Postmarketing reports...

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10 OVERDOSAGE

In one reported incident of acute overdose with SOMAVERT during pre-marketing clinical studies, a patient self-administered 80 mg/day (2.7 times the maximum recommended maintenance dosage) for seven days. The...

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11 DESCRIPTION

Pegvisomant is an analog of human growth hormone (GH) of recombinant DNA origin that acts as a GH receptor antagonist.

It contains 191 amino acid residues. The molecular weight of pegvisomant is 22 kDa....

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Pegvisomant selectively binds to growth hormone (GH) receptors on cell surfaces, where it blocks the binding of...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

A total of one hundred twelve patients (63 men and 49 women) with acromegaly participated in a 12-week, randomized, double-blind, multi-center study comparing placebo and SOMAVERT. The mean ±SD age was 48...

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16 HOW SUPPLIED/STORAGE AND HANDLING

SOMAVERT (pegvisomant) for injection is a white lyophilized powder supplied in the following strengths and package configurations:

...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients (and/or their caregivers) of the following information to...

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INSTRUCTIONS FOR USE

SOMAVERT® (SOM-ah-vert)
(pegvisomant)
for injection, for subcutaneous use

Read these...

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Resources

website

Somavert Website for Healthcare Professionals

website

Somavert Website for Consumers and Patients

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Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

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Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.