Details for: NGENLA
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02521679 | NGENLA | SOMATROGON | 20 MG / ML | SOLUTION | SUBCUTANEOUS |
| 02521687 | NGENLA | SOMATROGON | 50 MG / ML | SOLUTION | SUBCUTANEOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Ngenla is used for the long-term treatment of children who are not growing because of low growth hormone levels.
What it does
Ngenlahelps your child’s bones and muscles to grow and also helps your child’sfat and muscle tissues to develop in the right amounts. It is a modified form of human growth hormone which allows weekly dosing.
When it should not be used
- your child is allergic to somatrogon or any of the ingredients in Ngenla (see What are the ingredients in Ngenla? section).
- your child has an active tumour.
- your child isseriously ill due to complications following:
- open heart surgery,
- abdominal surgery,
- multiple accidental trauma, or
- acute respiratory failure
- Your child’s bones have already finished growing (this is called closure of the growth plates).
What the medicinal ingredient is
Medicinal ingredients: somatrogon
What the non-medicinal ingredients are
Non-medicinal ingredients: citric acid monohydrate, L-Histidine, m-Cresol, poloxamer 188, sodium chloride, trisodium citrate dihydrate, water for injection
What dosage form it comes in
Single-patient use prefilled pen containing:
- 24 mg of somatrogon in 1.2 mL (20 mg/mL); or
- 60 mg of somatrogon in 1.2 mL (50 mg/mL)
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your child’s healthcare professional before your child takes Ngenla. Talk about any health conditions or problems your child may have, including if your child:
- develops visual changes, headache, big change in behaviour, nausea and/or vomiting.
- is being treated with daily growth hormone therapy or are treated with glucocorticoid replacement. Your child’s doctor should monitor your child’s cortisol levels.
- is being treated with thyroid hormones. Your child’s doctor should monitor your child’s thyroid function.
- has diabetes. You should closely monitor your child’s blood sugar level during treatment with Ngenla. Discuss the results with your child’s doctor to determine if there is a need to change the dose of your child’s medicines to treat diabetes.
- starts to limp while being treated with Ngenla.
- has changes in skin colour or in the appearance of birthmarks or moles on the skin.
- has pain in their hip or knee.
- is pregnant or could become pregnant. Ngenla contains components that might interact with pregnancy tests. If your child needs to take a pregnancy test, it should be done before your child’s injection to reduce the risk of interference.
- is breast-feeding or plansto breast-feed.
- has signs of scoliosis
- has ever had any kind of tumour.
Interactions with this medication
Tell your child’s healthcare professional about all the medicines your child takes, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Ngenla:
- medicines used to treat diabetes.
- glucocorticoid treatments such as cortisone and prednisone.
- sex hormones (for example oral estrogens).
- cyclosporine (a medicine that weakens the immune system after transplantation).
- medicines to control epilepsy (anticonvulsants).
Proper use of this medication
How to take Ngenla:
Your child’s healthcare professional will show you how to inject Ngenlabefore using it for the first time. Do NOT try to inject Ngenlauntil you have been shown the right way by your child’s healthcare professional.
Ngenla is injected under the skin (subcutaneously) and can be given in the stomach (abdomen), thighs, buttocks or upper arms. Use a differentinjection site every week.
If your child needs more than one injection for a full dose, each one should be given at a different injection site.
Use Ngenlaonce weekly, on the same day each week, at any time of the day.
You may change the day of the week your child uses Ngenla as long as the last dose was given 3 or more days before.
Ngenlaprefilled pens are for use by 1 person only.
Do NOT share your child’s Ngenlaprefilled pens and needles with another person, even if the needle has been changed. Your childmay give another person an infection or get an infection from them.
Do NOT shake your child’s pen;shaking can damage the medicine.
Usual Dose:
The recommended dose is 0.66 mg/kg body weight injected once weekly. Your child’s healthcare professional will prescribe the dose of medicine that is right for your child. Your child’s doctor may perform regular blood tests to check how your child is responding to the treatment. Their dose may be changed according to blood test results, as necessary.
Overdose:
Missed Dose
If your childmisses a dose of Ngenla, take the missed dose as soon as possible within 3 days of the missed dose. If more than 3 days have passed, skip the missed dose and give your child the next dose on the regularly scheduled day.
Side effects and what to do about them
These are not all the possible side effects your child may have when taking Ngenla. If your child experiences any side effects not listed here, tell your child’s healthcare professional. Side effects may include:
Very common (may affect more than 1 in 10 people)
- injection site reactions including pain, redness, itching, swelling and/or local thickening of the skin
- fever
Common
- cold
- headache
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Respiratory tract infections: Cough; sneezing; nasal congestion; runny nose; fever; scratchy or sore throat. | ✔ | ||
| Skin infections: Redness of the skin and a rash; itching, pain, and tenderness. | ✔ | ||
| COMMON | |||
| Ear infections: Ear pain; fever; drainage from the ear that is thick and yellow or bloody; loss of appetite, vomiting, and grumpy behavior; trouble sleeping. | ✔ | ||
| Infection in the small intestine: Gas, bloating, diarrhea, abdominal pain or cramping; constipation. | ✔ | ||
| Pain or stiffness in the joints: stiffness in the arms and legs; joint pain; muscle pain | ✔ | ||
| Worsening of curvature of the spine (scoliosis): Back pain; one shoulder blade is higher than the other; one shoulder blade sticks out more than the other; uneven hips. | ✔ | ||
| UNCOMMON | |||
| Serious allergic reactions:swelling of the face, lips, mouth, or tongue; trouble breathing; wheezing; severe itching; skin rashes, redness, or swelling; dizziness or fainting; fast heartbeat or pounding the chest; sweating. | ✔ | ||
How to store
Prior to each use the pen can be left at room temperature for a more comfortable injection, not more than 32 °C for a maximum 2 hours. Do NOT use beyond the expiration date stamped on the carton.
Before first use (unused prefilled pens):
- Store your child’sNgenlapens in the refrigerator between 2°C to 8°C and in the original carton and away from direct sunlight.
- Do NOT freeze your child’s pen or expose it to heat.
- Unused prefilled pens may be used until the expiration date printed on the carton, if kept in the refrigerator.
After first use (up to 28 days of use):
- To help you remember when to dispose of your child’sNgenlapen, you can write the date of first use on the pen label.
- Store your child’s pen in the refrigerator at 2°C to 8°C in between each use and away from direct sunlight.
- Do NOT freeze your child’s pen or expose it to heat.
- Always remove and safely discard the needle after each injection. Do NOT store the pen with a needle attached.
- Always use a new needle for each injection.
- Keep the pen cap on your child’s pen when it is not in use.
- Discard your child’s pen when:
- the pen is empty or, has been used 5 times,
- the pen has been left out of the refrigerator (up to 32°C) for more than 2 hours with each use,
- the pen has been exposed to temperatures above 32°C; or
- it has been more than 28 days after first use, discard it even if it contains unused medicine.
Any unused product or waste material should be disposed of in accordance with local requirements.
When travelling, transport your child’sNgenlapen in its original carton in an insulated container with an ice pack. To avoid freezing, make sure your child’s pen does not touch the ice pack. Once you arrive, your child’s pen should be placed in a refrigerator as soon as possible. Do NOT leave it in a car or other place where it can get too hot or too cold.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-healthproducts/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html);the manufacturer’s website http://www.pfizer.ca, or by calling Pfizer Canada ULC at 1-800-463-6001.
This leaflet was prepared by Pfizer Canada ULC.
Last Revised October 26, 2021