Cegfila (previously Pegfilgrastim Mundipharma) · 4.6 Fertility, pregnancy and lactation · 1

HOS-099485 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common). Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics. Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1 000 to < 1/100]). Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon) (see section 4.4). Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1 000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below. Splenomegaly, generally asymptomatic, is uncommon. Splenic rupture including some fatal cases is uncommonly reported following administration of pegfilgrastim (see section 4.4). Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4). Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell disease (uncommon in sickle cell patients) (see section 4.4). Tabulated list of adverse reactions The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 MedDRA Adverse reactions system organ Very Common Uncommon Rare Very rare class common (≥ 1/10) (≥ 1/100 (≥ 1/1 000 (≥ 1/10 000 (< 1/10 000) to < 1/10) to < 1/100) to < 1/1 000) Neoplasms Myelodysplastic benign, syndrome1 malignant and Acute myeloid unspecified (incl

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HOS-099481 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099480 · has-indication-information · PDF-Seite 2

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

HOS-099483 · has-interaction-information · PDF-Seite 5

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Cegfila should be administered at least 24 hours after administration of cytotoxic chemotherapy. In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. Concomitant use of Cegfila with any chemotherapy agent has not been evaluated in patients. In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression. Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials. The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. There is no evidence that such an interaction would be harmful. The safety and efficacy of Cegfila have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas. Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.

HOS-099484 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Cegfila is not recommended during pregnancy and in women of childbearing potential not using contraception. 5 Breast-feeding There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cegfila therapy taking into account the benefit of breast- feeding for the child and the benefit of therapy for the woman. Fertility Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).

HOS-099482 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1). However, the long-term effects of Cegfila have not been established in AML; therefore, it should be used with caution in this patient population. Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro. The safety and efficacy of Cegfila have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and efficacy of Cegfila administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established. The safety and efficacy of Cegfila have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Pulmonary adverse events Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see section 4.8). The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). In such circumstances Cegfila should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8). Glomerulonephritis 3 Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended. Capillary leak síndrome Capillary leak syndrome has been reported after granulocyte-colony stimulating factor admin

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