Somavert

The first dose of Somavert (Pegvisomant), called a loading dose, is one dose of 40 mg given by subcutaneous (under the skin) injection. The first dose will be given by a health care professional. After this first dose, the recommended dose is 10 mg daily given by injection under the skin of the upper arm, upper thigh, stomach area, or buttocks.

Your doctor may increase or decrease the dose of Somavert (Pegvisomant) depending on the results of IGF-I (a type of hormone) levels in your blood. The maximum dose is 30 mg daily. The place of injection should be changed daily to avoid skin problems associated with repeated injection at the same site.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you are injecting Somavert (Pegvisomant) yourself, your doctor will show you how to use Somavert (Pegvisomant) properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using Somavert (Pegvisomant), thoroughly read the patient information provided and ask your doctor if you have any questions. If a caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.

The injection must be given within 3 hours of preparing it. The solution for injection should be clear. If it is cloudy, discoloured, or has particles in it, do not use the injection.

It is important to use Somavert (Pegvisomant) exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the powder form of Somavert (Pegvisomant) in the refrigerator, do not allow it to freeze, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

10 mg
Each single-dose vial of sterile, white lyophilized powder for subcutaneous injection after reconstitution with 1 mL of sterile water for injection, contains 10 mg of Somavert (Pegvisomant) protein. Nonmedicinal ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate. The stopper in the vial may contain latex.

15 mg
Each single-dose vial of sterile, white lyophilized powder for subcutaneous injection after reconstitution with 1 mL of sterile water for injection, contains 15 mg of Somavert (Pegvisomant) protein. Nonmedicinal ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate. The stopper in the vial may contain latex.

20 mg
Each single-dose vial of sterile, white lyophilized powder for subcutaneous injection after reconstitution with 1 mL of sterile water for injection, contains 20 mg of Somavert (Pegvisomant) protein. Nonmedicinal ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate. The stopper in the vial may contain latex.

25 mg
Each single-dose vial of sterile, white lyophilized powder for subcutaneous injection after reconstitution with 1 mL of sterile water for injection, contains 25 mg of Somavert (Pegvisomant) protein. Nonmedicinal ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate. The stopper in the vial may contain latex.

30 mg
Each single-dose vial of sterile, white lyophilized powder for subcutaneous injection after reconstitution with 1 mL of sterile water for injection, contains 30 mg of Somavert (Pegvisomant) protein. Nonmedicinal ingredients: glycine, mannitol, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate. The stopper in the vial may contain latex.

Do not use Somavert (Pegvisomant) if you are allergic to Somavert (Pegvisomant) or any ingredients of the medication.

There may be an interaction between Somavert (Pegvisomant) and any of the following:

• diabetes medication taken by mouth (e.g., Acarbose, Glyburide, Gliclazide, Metformin, Rosiglitazone, Tolbutamide)
• insulin
• octreotide and other somatostatin analogues
• opioid pain medications (e.g., Morphine, Codeine, Oxycodone, Tramadol)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Somavert (Pegvisomant). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Somavert (Pegvisomant).

Diabetes: Somavert (Pegvisomant) may lower blood glucose levels. If you have diabetes, discuss with your doctor how Somavert (Pegvisomant) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somavert (Pegvisomant), and whether any special monitoring is needed.

Latex: The stopper of the vials of Somavert (Pegvisomant) may contain latex.

Liver function: Somavert (Pegvisomant) may cause an increase in liver function test values and may cause liver problems. Your doctor will monitor your liver function with regular blood tests while you are taking Somavert (Pegvisomant). Using Somavert (Pegvisomant) in combination with Octreotide (another medication to treat acromegaly) may increase the risk of liver damage due to the medication.

If you experience yellowing of the skin or eyes, abdominal pain, nausea, vomiting, loss of appetite, fatigue, or easy bruising while taking Somavert (Pegvisomant), contact your doctor immediately.

If you have liver disease or decreased liver function, discuss with your doctor how Somavert (Pegvisomant) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Somavert (Pegvisomant), and whether any special monitoring is needed.

Tumour growth: Somavert (Pegvisomant) may cause tumours that secrete growth hormones to grow. If you have such a tumour, you doctor will monitor you closely while you are using Somavert (Pegvisomant).

Pregnancy: Somavert (Pegvisomant) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Somavert (Pegvisomant), contact your doctor immediately.

Breast-feeding: It is not known if Somavert (Pegvisomant) passes into breast milk. If you are a breast-feeding mother and are taking Somavert (Pegvisomant), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Somavert (Pegvisomant) have not been established for children.

Seniors: There is limited information about the safety and effectiveness of using Somavert (Pegvisomant) for seniors.