Serostim 5.83 mg-in-mL - Consumer Medicine Information
|Manufacture:||EMD Serono, Inc|
|Condition:||AIDS Related Wasting, Cachexia, HIV (HIV Infection), Prader-Willi Syndrome, Short Stature for Age|
|Form:||Subcutaneous (SC), Powder|
|Ingredients:||somatropin, sucrose, phosphoric acid|
(Somatropin for injection)
About This Medication
What Serostim is Used For
SEROSTIM is indicated for the treatment of HIV wasting associated with catabolism, weight loss or cachexia.
What Does Serostim Do
HIV-associated wasting is a metabolic disorder characterized by specific abnormalities of intermediary metabolism resulting in weight loss, inappropriate depletion of lean body mass (LBM), and paradoxical preservation of body fat. LBM includes primarily skeletal muscle, organ tissue, blood and blood constituents. LBM depletion results in muscle weakness, organ failure, immune deficiency, general inanition and death. Unlike nutritional intervention for HIV-associated wasting, in which supplemental calories are converted predominantly to body fat which is essentially inert in day-to -day metabolic balance, the anabolic and anti-catabolic effects of SEROSTIM treatment resulted in a prompt and sustained increase in LBM and a decrease in body fat with a significant increase in body weight due to the dominant effect of LBM gain.
When Should Serostim not be Used
SEROSTIM should not be used in the following patient groups:
- in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or patients having acute respiratory failure.
- in the presence of any progression of underlying intracranial tumour. Intracranial tumour should be inactive and anti-malignancy treatment must be completed with evidence of remission prior to instituting therapy and SEROSTIM should be discontinued if there is evidence of recurrent activity. Patients should be examined frequently for progression or recurrence of the underlying disease process.
- patients who are hypersensitive to growth hormone or to any ingredient in the formulation, or component of the container.
- patients with active neoplasia (either newly diagnosed or recurrent). Any anti-tumour therapy should be completed prior to starting therapy with SEROSTIM and should be discontinued if there is evidence of recurrent tumor growth.
- patients with diabetes mellitus.
- patients with proliferative or preproliferative diabetic retinopathy.
The Medicinal Ingredient in Serostim
The common name of the active ingredient in SEROSTIM is somatropin.
The Nonmedicinal Ingredients in Serostim
Each vial of SEROSTIM 8.8 mg (5.83 mg/ml) click.easy contains the following non-medicinal ingredients: Sucrose, phosphoric acid and sodium hydroxide. The diluent which comes with SEROSTIM 8.8 mg (5.83 mg/ml) click.easy is sterile water containing a preservative called metacresol along with phosphoric acid.
What Dosage Forms of Serostim are Available
SEROSTIM 8.8mg (5.83 mg/ml) click.easy comes as a powder in a vial along with a cartridge of diluent (0.3% metacresol in water for injection: 1.51 mL) pre-assembled in a reconstitution device (click.easy). The final concentration that will be injected is 5.83 mg/mL.
Note: SEROSTIM is also available in 4 mg, 5 mg and 8.8 mg vials, each with vials of diluent, instead of a cartridge and without the reconstitution device.
Warnings and Precautions
Before you use SEROSTIM talk to your doctor or pharmacist if:
- you are hypersensitive to somatropin or to any of the other ingredients of SEROSTIM
- you are pregnant or breastfeeding
- you have an acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory failure
- you develop hyperglycemia
- you experience increased tissue turgor (non-edematous swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness)
- you experience carpal tunnel syndrome
During clinical trials in which all patients received anti-retroviral therapy there were no detectable increases in plasma viral load following SEROSTIM therapy. Patients with AIDS wasting considered for treatment with SEROSTIM should also receive approved anti-retroviral therapy.
No formal interaction studies have been performed in patients treated with SEROSTIM.
Interactions with food, herbal products and laboratory tests have not been established.
Proper Use of This Medication
SEROSTIM should be administered subcutaneously daily at bedtime according to the following dosage recommendations:
|> 55 kg||6 mg SC daily|
|45-55 kg||5 mg SC daily|
|35-45 kg||4 mg SC daily|
* Based on an approximate daily dosage of 0.1mg/kg
In patients who weigh less than 35 kg, SEROSTIM should be administered at a dose of 0.1 mg/kg subcutaneously daily at bedtime.
Treatment with the medicinal product should be initiated under the supervision of a specialised physician.
Preparing Serostim for Administration
Serostim 8.8 mg (5.83 mg/mL) click.easy
The product (powder in vial) must be reconstituted with the bacteriostatic diluent (0.3%(w/v) metacresol in water for injections) provided using the click.easy reconstitution device. The reconstitution solution is intended for subcutaneous administration (under the skin) and should be clear with no particles. If the solution contains particles, it must not be injected.
Patients should be thoroughly instructed in the reconstitution procedures.
For administration of SEROSTIM 8.8mg (5.83 mg/ml) please read the following instructions carefully.
- Make sure the click.easy reconstitution device is complete by checking that the SEROSTIM vial (a), the sterile transfer cannula (b), and the diluent cartridge (c) are present.
- Check that both the tamper evident seals on the vial container (d) and on the cap (e) are not broken. (picture of tamper evident seal magnified). Do not use the device if the tamper evident seal on the cap is broken, and return it to your pharmacist or doctor.
How to Reconstitute
- Wash your hands with soap and water.
- Find a clean area and lay out the elements needed for the preparation of the solution and the injection.
1) Place the click.easy reconstitution device vertically on a flat surface with the vial at the bottom and the locking cap facing upward. 2) Push on the cap firmly until the vial container is completely inside the main body (Note: the tamper evident seal on the vial container is now broken). 3) Turn the cap clockwise until the green button (f) is visible. Push the cap down very slowly until it will go no further to transfer the diluent from the cartridge into the vial.(Note: the tamper evident seal on the cap is now broken). Check that all the diluent has been transferred into the vial. Dissolve the powder with the diluent by gently swirling the click.easy (Note: A fast transfer of the diluent or shaking will create more foam). Let the solution stand for 2-5 minutes until the powder is completely dissolved. 4) Push the cap back down until it will go no further and keep it in position. Turn the click.easy upside down and pull the cap slowly downwards until the solution is completely drawn back into the cartridge. Check that no more than one or two drops of solution remain in the vial. If there are more than one or two drops of solution remaining in the vial, slowly push the cap up until some of the solution is back in the vial and gently tap the click.easy. Then draw the solution slowly again back into the cartridge. Remove any excess air that has been drawn into the cartridge by pushing slowly the cap up until no air is visible in the cartridge (Note: Avoid pulling the cap down too fast, as this will draw air into the cartridge). 5) Turn the click.easy so that the cap is again on the top. Unscrew the cap and remove it. 6) Remove the cartridge containing the reconstituted solution for injection from the click.easy. Carefully peel off the outer label using the tab provided. Write the reconstitution date on the transparent inner label on the cartridge. Discard the click.easy safely in accordance with your local requirements. The cartridge containing the reconstituted solution of SEROSTIM is now ready to be used with the one.click auto-injector. NOTE: For instructions on how to load the cartridge into the one.click auto-injector and inject the reconstituted solution of SEROSTIM please read the instructions that have been provided at the end of this leaflet.
NOTE: Injections should be given in different parts of your body. Do not use any areas in which you feel lumps, firm knots, depressions, or pain; talk to your doctor or healthcare professional about anything you find. Clean the skin at the injection site with soap and water.
NOTE: Although SEROSTIM 8.8 mg (5.83 mg/ml) in the click.easy device is intended for the one.click auto-injector, SEROSTIM 8.8 mg (5.83 mg/ml) click.easy, once reconstituted, can also be accessed with a conventional syringe for a subcutaneous injection.
There is no known antidote to SEROSTIM or any specific treatment for SEROSTIM overdose other than withholding treatment and patient observation. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you forget to take an injection on your usual day of the week, do not double your next injection. If you have forgotten more than one injection, contact your physician for advice on how to proceed.
Side Effects and What to Do About Them
The most common adverse reactions reported in the clinical trial and felt to be associated with SEROSTIM were musculoskeletal discomfort and increased tissue turgor (non-edematous swelling, particularly of the hands or feet) . These symptoms were generally rated by investigators as mild to moderate in severity and usually subsided with continued treatment.
Clinical adverse events which occurred during the first 12 weeks of study in at least 10% of those who received SEROSTIM during the two placebo-controlled trials are listed below by treatment group.
Adverse Event SEROSTIM
Musculoskeletal discomfort 53.7 33.3 Fever 31.2 29.3 Increased tissue 27.3 2.7 Diarrhea 25.9 20 Neuropathy 25.9 17.3 Nausea 25.9 16 Headache 19 20.7 Abdominal pain 17.1 18.7 Fatigue 17.1 16 Leukopenia 15.1 24.7 Albuminuria 15.1 9.3 Granulocytopenia 14.1 21.3 Lymphadenopathy 14.1 16 Anorexia 12.2 8.7 Anemia 12.2 9.3 Vomiting 11.7 8.7 SGOT increased 11.7 12 Insomnia 11.2 9.3 Tachycardia 11.2 6 Hyperglycemia 10.2 6 SGPT increased 10.2 5.3
This is not a complete list of side effects. If you experience any unusual symptoms or side effects, you should report them to the doctor immediately. It is also wise to discuss the possibility of side effects with the doctor before beginning treatment.
How to Store Serostim
Unopened vials of SEROSTIM 8.8 mg (5.83 mg/ml) click.easy are stable for 3 years from the time of manufacture.
Vials of SEROSTIM 8.8 mg (5.83 mg/ml) pre-assembled in the click.easy® reconstitution device should be stored in the original package at room temperature (25°C or below).
SEROSTIM reconstituted solution should be stored at 2ºC to 8°C in the cartridge and should be used within 28 days.
Do not freeze.
It is important not to use the medicine:
- after the date shown on the vial label
- in case of apparent deterioration.
Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The CanadaVigilance Program does not provide medical advice
This document plus the full Product Monograph, prepared for health care professionals can be obtained from
EMD Serono, A Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga, Ontario, Canada