Applies to pegcetacoplan: subcutaneous solution.
Warning
Subcutaneous route (Solution)
Warning: Serious Infections Caused by Encapsulated BacteriaMeningococcal infections may occur in patients treated with pegcetacoplan and may become rapidly life-threatening or fatal if not recognized and treated early. Use of pegcetacoplan may predispose individuals to serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B and Haemophilus influenzae type B.Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients with altered immunocompetence associated with complement deficiencies.Vaccinate patients against encapsulated bacteria as recommended at least 2 weeks prior to administering the first dose of pegcetacoplan unless the risks of delaying therapy with pegcetacoplan outweigh the risk of developing a serious infection.Vaccination reduces, but does not eliminate, the risk of serious infections. Monitor patients for early signs of infections and evaluate immediately if infection is suspected.Pegcetacoplan is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the EMPAVELI REMS, prescribers must enroll in the program. Enrollment in the EMPAVELI REMS program and additional information are available by telephone: 1-888-343-7073 or at www.empavelirems.com.
Serious side effects of Pegcetacoplan
Along with its needed effects, pegcetacoplan 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 pegcetacoplan:
More common
- Black, tarry stools
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- bloody vomit
- blurred vision
- body aches or pain
- change in the color, amount, or odor of the vaginal discharge
- chest pain, discomfort, or tightness
- chills
- confusion
- cough or hoarseness
- cough producing mucus
- decreased urine
- diarrhea
- difficulty in breathing
- dizziness
- dry mouth
- ear congestion
- fainting
- fever
- flu-like symptoms
- general feeling of discomfort or illness
- headache
- increased thirst
- irregular heartbeat
- lightheadedness
- loss of appetite
- loss of voice
- mood changes
- muscle aches, pain, or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- pinpoint red spots on the skin
- pounding in the ears
- rapid, shallow breathing
- rapid weight gain
- seizures
- slow or fast heartbeat
- sneezing
- sore throat
- severe stomach pain
- sleepiness
- stuffy or runny nose
- thickening of bronchial secretions
- tingling of the hands or feet
- trouble breathing
- tooth or gum pain
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Other side effects of Pegcetacoplan
Some side effects of pegcetacoplan 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
- Arm or leg pain
- bloody nose
- diarrhea
- difficulty in moving
- heartburn
- joint pain
- lack or loss of strength
- large, flat, blue or purplish patches in the skin
- pain in the lower back, bottom, hips, or upper legs
- unusual drowsiness, dullness, or feeling of sluggishness
For Healthcare Professionals
Applies to pegcetacoplan: subcutaneous solution.
Hypersensitivity
Common (1% to 10%): Chest pain,[Ref]
Musculoskeletal
Common (1% to 10%): Back pain[Ref]
Respiratory
Very common (10% or more): Respiratory tract infection (15%)
Frequency not reported: Hypersensitivity pneumonitis[Ref]
Other
Very common (10% or more): Viral Infection (12%), infections (29%)[Ref]
Nervous system
Very common (10% or more): Fatigue (12%)
Common (1% to 10%): Headache[Ref]
Cardiovascular
Common (1% to 10%): Systemic hypertension, chest pain[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (22%), abdominal pain (20%)[Ref]
Local
Very common (10% or more): Injection site reaction (39%)[Ref]
Hepatic
Frequency not reported: Biliary sepsis[Ref]
