TREMEFA (Tremfya/Guselkumab) Side Effects
The most common side effects of TREMEFA (Tremfya/guselkumab) include upper respiratory infections, headache, injection site reactions, joint pain, diarrhea, gastroenteritis, fungal skin infections, and herpes simplex infections.
Common Side Effects
- Upper respiratory infections: Most frequently reported adverse effect
- Injection site reactions: Pain, redness, bruising at injection sites (occurs in 5-20% of patients)
- Headache
- Joint pain (arthralgia)
- Diarrhea
- Gastroenteritis
- Fungal skin infections
- Herpes simplex infections
Serious Side Effects
Allergic Reactions
- Anaphylaxis: Reported in approximately 0.2% of treated patients
- Hypersensitivity reactions
Infections
- Increased risk of infections: Due to immunosuppressive effects
- Tuberculosis: Patients should be evaluated for TB before starting treatment
Malignancy
- Malignant neoplasms: Reported in 0.5% of patients compared with 0.2% receiving placebo
Monitoring Recommendations
Before Starting Treatment
- Tuberculosis screening
- Evaluation for active infections
- Assessment of vaccination status (live vaccines should be avoided)
During Treatment
- Monitor for signs of infection
- Watch for symptoms of allergic reactions
- Regular skin examinations
Special Populations
Pregnancy
- Limited data on use during pregnancy
- Risk-benefit assessment needed before use
Elderly
- No specific dose adjustments required
- May have increased sensitivity to side effects
Administration Considerations
- Administered as subcutaneous injection
- Proper injection site rotation is important to minimize local reactions
- Patients should be observed after administration, particularly during early treatments
Practical Management Tips
Injection site reactions can be minimized by:
- Allowing solution to reach room temperature before injection
- Rotating injection sites
- Avoiding areas with active skin conditions
For mild upper respiratory symptoms:
- Symptomatic treatment is usually sufficient
- Severe or persistent symptoms warrant medical evaluation
Patients should be educated about recognizing signs of serious infections or allergic reactions requiring immediate medical attention
TREMEFA is generally well-tolerated with a safety profile similar to other biologic agents used for immune-mediated conditions, but patients should be monitored for the potential side effects listed above.