Please see adverse reactions on the next tab.
Additional information about the PLEGRIDY Warnings and Precautions1
Hepatic Injury
Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, have been reported with interferon beta. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with interferon beta.
- Elevations of serum hepatic transaminases combined with elevated bilirubin occurred in 2 patients. Both cases resolved following discontinuation of PLEGRIDY.
- Monitor patients for signs and symptoms of hepatic injury.
Depression and Suicide
Depression, suicidal ideation, and suicide occur more frequently in patients receiving interferon beta than in patients receiving placebo.
- The incidence of serious events related to depression and suicidal ideation was similar and less than 1% in both groups.
- Advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider.
- If a patient develops depression or other severe psychiatric symptoms, consider stopping treatment with PLEGRIDY.
Seizures
Seizures are associated with the use of interferon beta.
- Exercise caution when administering PLEGRIDY to patients with a seizure disorder.
Anaphylaxis and Other Allergic Reactions
Anaphylaxis and other serious allergic reactions are rare complications of treatment with interferon beta.
- Discontinue PLEGRIDY if a serious allergic reaction occurs.
Injection Site Reactions (ISRs)
ISRs, including injection site necrosis, can occur with the use of subcutaneous interferon beta.
- The incidence of severe injection site reactions was 3% in the PLEGRIDY group and 0% in the placebo group.
- One patient out of 1,468 patients who received PLEGRIDY in clinical studies experienced injection site necrosis. The injury resolved with standard medical treatment.
- Decisions to discontinue therapy following necrosis at a single injection site should be based on the extent of the necrosis.
- For patients who continue therapy with PLEGRIDY after injection site necrosis has occurred, avoid administration of PLEGRIDY near the affected area until it is fully healed.
- If multiple lesions occur, discontinue PLEGRIDY until healing occurs.
Congestive Heart Failure
Congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta.
- Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of treatment with PLEGRIDY.
Decreased Peripheral Blood Counts
Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia.
- The incidence of clinically significant decreases in lymphocyte counts (below 0.5 x 109/L), neutrophil counts (below 1.0 x109/L), and platelet counts (below 100 x 109/L) were all less than 1% and similar in both placebo and PLEGRIDY groups.
- Two serious cases were reported in patients treated with PLEGRIDY: one patient (less than 1%) experienced severe thrombocytopenia (defined as a platelet count less than or equal to 10 x 109/L), and another patient (less than 1%) experienced severe neutropenia (defined as a neutrophil count less than or equal to 0.5 x 109/L). In both patients, cell counts recovered after discontinuation of PLEGRIDY. Compared to placebo, there were no significant differences in red blood cell counts in patients treated with PLEGRIDY.
- Monitor patients for infections, bleeding, and symptoms of anemia.
- Monitor complete blood cell counts, differential white blood cell counts, and platelet counts during treatment with PLEGRIDY. Patients with myelosuppression may require more intensive monitoring of blood cell counts.
Thrombotic Microangiopathy
Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with interferon beta products. Cases have been reported several weeks to years after starting interferon beta products.
- Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
Autoimmune Disorders
Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta.
- If patients develop a new autoimmune disorder, consider stopping PLEGRIDY.
Please see warnings and precautions on the previous tab.
Monitoring considerations with PLEGRIDY1
- Monitor patients for signs and symptoms of hepatic injury
- Advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider. If a patient develops depression or other severe psychiatric symptoms, consider stopping treatment with PLEGRIDY
- Exercise caution when administering PLEGRIDY to patients with a seizure disorder
- Discontinue PLEGRIDY if a serious allergic reaction occurs
- Decisions to discontinue therapy following necrosis at a single injection site should be based on the extent of the necrosis. For patients who continue therapy with PLEGRIDY after injection site necrosis has occurred, avoid administration of PLEGRIDY near the affected area until it is fully healed. If multiple lesions occur, discontinue PLEGRIDY until healing occurs
- Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of treatment with PLEGRIDY
- Monitor patients for infections, bleeding, and symptoms of anemia. Monitor complete blood cell counts, differential white blood cell counts, and platelet counts during treatment with PLEGRIDY. Patients with myelosuppression may require more intensive monitoring of blood cell counts
- Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated
- If patients develop a new autoimmune disorder, consider stopping PLEGRIDY