NGENLA

Generic Name/API: somatrogon-ghla

Manufacturer: Pfizer Ireland Pharmaceuticals

Dosage Forms & Strength & Pack Size:
Injection:
24 mg/1.2 mL (20 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.2 mg increments.
60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.5 mg increments.

Storage:
Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to
protect from light.
After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each
use, for up to 28 days.
Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store
away from direct sunlight.
Always remove and safely discard the needle after each injection and store the NGENLA
prefilled pen without an injection needle attached. Always use a new needle for each
injection. Replace the cap on your prefilled pen when it is not in use. Write the date of
first use in the space provided on the pen label. The prefilled pen should not be used
more than 28 days after first use.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
NGENLA is a prescription product for the treatment of growth failure in children 3 years of age and older who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD).

IMPORTANT SAFETY INFORMATION
Growth hormone should not be used in children after the growth plates have closed.
Growth hormone should not be used in children with some types of eye problems caused by diabetes (diabetic retinopathy).
Growth hormone should not be used in children who have cancer or other tumors.
Growth hormone should not be used in children who are critically ill because of some types of heart or stomach surgery, trauma, or breathing (respiratory) problems.
Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have breathing problems including sleep apnea.
NGENLA should not be used by children who have had an allergic reaction to somatrogon-ghla or any of the ingredients in NGENLA. Look for prompt medical attention in case of an allergic reaction.
Some children have developed diabetes mellitus while taking growth hormone. Dosages of diabetes medicines may need to be adjusted during treatment with NGENLA. Children should be watched carefully if NGENLA is given along with glucocorticoid therapy and/or other drugs that are processed by the body in the same way.
In childhood cancer survivors, treatment with growth hormone may raise the likelihood of a new tumor, particularly some benign (non-cancerous) brain tumors. This likelihood may be higher in children who were treated with radiation to the brain or head. Your child’s health care provider will need to check your child for a return of cancer or a tumor.
Children treated with growth hormone have had increased pressure in the brain. If your child has headaches, eye problems, nausea (feeling like you are going to be sick), or vomiting, contact your child’s health care provider.
NGENLA may decrease thyroid hormone levels. Decreased thyroid hormone levels may change how well NGENLA works. Your child’s health care provider will do blood tests to check your child’s hormone levels.
Children treated with growth hormone should be checked regularly for low serum cortisol levels and/or the need to increase the dose of the glucocorticoids they are taking.
In children experiencing fast growth, curvature of the spine may develop or worsen. This is also called scoliosis. Children with scoliosis should be checked regularly to make sure their scoliosis does not get worse during their growth hormone therapy.
Use a different area on the body for each injection. This can help to avoid skin problems such as lumpiness or soreness.
Growth hormone treatment may cause serious and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s health care provider if your child has any new stomach (abdominal) pain.
In studies of NGENLA in children with GHD, side effects included injection site reactions such as pain, swelling, rash, itching, or bleeding. Other side effects were the common cold, headache, fever (high temperature), low red blood cells (anemia), cough, vomiting, decreased thyroid hormone levels, stomach pain, rash, or throat pain.
A health care provider will help you with the first injection. He or she will also train you on how to inject NGENLA.

Rx only

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