SIDE EFFECTS WITH COPIKTRA
What to be aware of and what you can do.
Being aware of the possible side effects that you could experience while on COPIKTRA can help you and your healthcare team work out the best way to manage your treatment plan. Calling your doctor promptly is critical in addressing side effects.
It is important to tell your doctor about all side effects that you experience while taking COPIKTRA.
Your doctor may change your dose, pause your treatment, or completely stop it if you develop certain side effects during treatment with COPIKTRA.
What is the most important information I should know about COPIKTRA?
COPIKTRA can cause serious side effects, including:
- Infections. Infections are common during COPIKTRA treatment and can be serious and can lead to death. Tell your healthcare provider right away if you have a fever, chills, or other signs of an infection during treatment with COPIKTRA.
- Diarrhea or inflammation of your intestine. Diarrhea or inflammation of your intestine (colitis) is common during COPIKTRA treatment and can be serious and can lead to death. Your healthcare provider may prescribe an antidiarrhea medicine for your diarrhea. Tell your healthcare provider right away if you have any new or worsening diarrhea, stool with mucus or blood, or if you have severe stomach-area (abdominal) pain. Your healthcare provider should prescribe medicine to help your diarrhea and check you at least weekly. If your diarrhea is severe or anti-diarrhea medicines did not work, you may need treatment with a steroid medicine.
- Skin reactions. Rashes are common with COPIKTRA treatment. COPIKTRA can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening skin rash, or other skin reactions during treatment with COPIKTRA, including:
- painful sores or ulcers on your skin, lips, or in your mouth
- severe rash with blisters or peeling skin
- rash with itching
- rash with fever
Your healthcare provider may need to prescribe medicines, including a steroid medicine, to help treat your skin rash or other skin reactions.
- Inflammation of the lungs. COPIKTRA can cause inflammation of your lungs which can be serious and can lead to death. Tell your healthcare provider right away if you get new or worsening cough or difficulty breathing. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with COPIKTRA. Your healthcare provider may treat you with a steroid medicine if you develop inflammation of the lungs that is not due to an infection.
- Elevated liver enzymes. COPIKTRA may cause abnormalities in liver blood tests. Your healthcare provider should do blood tests during your treatment with COPIKTRA to check for liver problems. Tell your healthcare provider right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), pain in the abdominal region, bruising or bleeding more easily than normal.
- Low white blood cell count (neutropenia). Neutropenia is common with COPIKTRA treatment and can sometimes be serious. Your healthcare provider should check your blood counts regularly during treatment with COPIKTRA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with COPIKTRA.
These are not all the possible side effects of COPIKTRA.
- Please call your healthcare provider to discuss.
- Calling your doctor promptly is critical in addressing side effects.
- There may be things that your doctor can do to help manage your side effects.
These are not all the possible side effects of COPIKTRA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 and to Secura Bio at 1-844-9SECURA (1-844-973-2872).
Talk to your doctor about the possible side effects of COPIKTRA.
- Your doctor has prepared you for potential side effects.
- While some serious side effects may cause patients to stop taking COPIKTRA altogether, other side effects may be managed through dose modification, additional medications, or other techniques.
- Always talk with your healthcare team to determine how to best manage side effects.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infections: Serious, including fatal (4%), infections occurred in 31% of patients receiving COPIKTRA (N=442). The most common serious infections were pneumonia, sepsis, and lower respiratory infections. Median time to onset of any grade infection was 3 months, with 75% of cases occurring within 6 months. Treat infections prior to initiation of COPIKTRA. Advise patients to report new or worsening signs and symptoms of infection. Cases of Pneumocystis jirovecii pneumonia (PJP) (1%) and cytomegalovirus (CMV) reactivation/infection (1%) occurred in patients taking COPIKTRA. Provide prophylaxis for PJP during treatment and following completion of treatment until the absolute CD4+ T cell count is greater than 200 cells/μL. Consider prophylactic antivirals during COPIKTRA treatment to prevent CMV infection including CMV reactivation.
Diarrhea or Colitis: Serious, including fatal (<1%), diarrhea or colitis occurred in 18% of patients receiving COPIKTRA (N=442). Median time to onset of any grade diarrhea or colitis was 4 months, with 75% of cases occurring by 8 months. The median event duration was 0.5 months. Advise patients to report any new or worsening diarrhea.
Cutaneous Reactions: Serious, including fatal (<1%), cutaneous reactions occurred in 5% of patients receiving COPIKTRA (N=442). Fatal cases included drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN). Median time to onset of any grade cutaneous reaction was 3 months with a median event duration of 1 month. Presenting features for the serious events were primarily described as pruritic, erythematous, or maculo-papular. Less common presenting features include exanthem, desquamation, erythroderma, skin exfoliation, keratinocyte necrosis, and papular rash. Advise patients to report new or worsening cutaneous reactions.
Pneumonitis: Serious, including fatal (<1%), pneumonitis without an apparent infectious cause occurred in 5% of patients receiving COPIKTRA (N=442). Median time to onset of any grade pneumonitis was 4 months with 75% of cases occurring within 9 months. The median event duration was 1 month with 75% of cases resolving by 2 months.
Hepatotoxicity: Grade 3 and 4 ALT and/or AST elevation developed in 8% and 2%, respectively, of patients receiving COPIKTRA (N=442). Two percent of patients had both an ALT or AST > 3 X ULN and total bilirubin > 2 X ULN. Median time to onset of any grade transaminase elevation was 2 months with a median event duration of 1 month. Monitor hepatic function during treatment with COPIKTRA.
Neutropenia: Grade 3 or 4 neutropenia occurred in 42% of patients receiving COPIKTRA (N=442), with Grade 4 neutropenia occurring in 24% of all patients. Median time to onset of grade ≥3 neutropenia was 2 months. Monitor neutrophil counts at least every 2 weeks for the first 2 months of COPIKTRA therapy, and at least weekly in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4).
Embryo-Fetal Toxicity: COPIKTRA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus and conduct pregnancy testing before initiating COPIKTRA treatment. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 1 month after the last dose.
B-cell Malignancies Summary
Fatal adverse reactions within 30 days of the last dose occurred in 8% (36/442) of patients treated with COPIKTRA 25 mg BID. Serious adverse reactions were reported in 289 patients (65%). The most frequent serious adverse reactions that occurred were infection (31%), diarrhea or colitis (18%), pneumonia (17%), rash (5%), and pneumonitis (5%). The most common adverse reactions (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia.
Fatal adverse reactions within 30 days of the last dose occurred in 12% (19/158) of patients treated with COPIKTRA and in 4% (7/155) of patients treated with ofatumumab. Serious adverse reactions were reported in 73% (115/158) of patients treated with COPIKTRA and most often involved infection (38%; 60/158) and diarrhea or colitis (23%; 36/158). The most common adverse reactions with COPIKTRA (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, pyrexia, upper respiratory tract infection, pneumonia, rash, fatigue, nausea, anemia and cough.
For specific information on the management of the adverse reactions above, please review Dose Modifications for Adverse Reactions within the full Prescribing Information.
CYP3A4 Inducers: Coadministration with a strong or moderate CYP3A inducer may reduce COPIKTRA efficacy. Avoid coadministration with strong or moderate CYP3A4 inducers.
CYP3A4 Inhibitors: Coadministration with a strong CYP3A4 inhibitor may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dose when coadministered with a strong CYP3A4 inhibitor.
CYP3A4 Substrates: Coadministration of COPIKTRA with sensitive CYP3A4 substrates may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A4 substrate.
Please see accompanying full Prescribing Information, including Boxed Warning.
To report Adverse Reactions during use of COPIKTRA, contact Secura Bio, call 1-844-9Secura or 1-844-973-2872 and/or to FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.