Applies to lonapegsomatropin: subcutaneous powder for solution.
Serious side effects of Lonapegsomatropin
Along with its needed effects, lonapegsomatropin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking lonapegsomatropin:
More common
- Bleeding gums
- blood in the eye
- bruise
- coughing up blood
- difficulty in breathing or swallowing
- dizziness
- eye pain
- headache
- increased menstrual flow or vaginal bleeding
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- redness in the whites of the eyes
- small, red, or purple spots on the skin
- trouble breathing
Incidence not known
- Bloating
- chest tightness
- chills
- confusion
- constipation
- cough
- darkening of the skin
- decrease in amount of urine
- depression or indentation of the skin
- diarrhea
- dry skin and hair
- fainting
- fast heartbeat
- feeling cold
- fever
- general feeling of discomfort or illness
- hair loss
- hives, itching, skin rash
- hoarseness or husky voice
- indigestion
- joint pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- limp pain in the hip or knee
- loss of appetite
- mental depression
- muscle aches, pains, cramps, and stiffness
- noisy, rattling breathing
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- runny nose
- severe nausea and vomiting
- shivering
- slowed heartbeat
- sore throat
- sweating
- swelling of the fingers, hands, feet, or lower legs
- trouble sleeping
- unusual tiredness or weakness
- vision changes
- weight gain
- yellow eyes or skin
Other side effects of Lonapegsomatropin
Some side effects of lonapegsomatropin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty in moving
- stomach pain
For Healthcare Professionals
Applies to lonapegsomatropin: subcutaneous injection.
General
The most common adverse events were viral infection, pyrexia, cough, and nausea and vomiting.[Ref]
Immunologic
Very common (10% or more): Viral infection (15%)[Ref]
Other
Very common (10% or more): Pyrexia (15%)
Frequency not reported: Increased mortality in patients with acute critical illness, sudden death in pediatric patients with Prader-Willi syndrome[Ref]
Gastrointestinal
Very common (10% or more): Nausea and vomiting (11%)
Common (1% to 10%): Diarrhea, abdominal pain
Frequency not reported: Pancreatitis[Ref]
Hematologic
Common (1% to 10%): Hemorrhage[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia and arthritis
Frequency not reported: Slipped capital femoral epiphysis in pediatric patients, progression of preexisting scoliosis in pediatric patients[Ref]
Hypersensitivity
Frequency not reported: Severe hypersensitivity[Ref]
Respiratory
Very common (10% or more): Cough (11%)[Ref]
Nervous system
Frequency not reported: Intracranial hypertension[Ref]
Oncologic
Frequency not reported: Increased risk of neoplasms[Ref]
Metabolic
Frequency not reported: Glucose intolerance and diabetes mellitus, fluid retention, elevated phosphate and alkaline phosphatase levels[Ref]
Endocrine
Frequency not reported: Hypoadrenalism, hypothyroidism[Ref]
