Lenograstim is indicated in adults, adolescents, and children aged older than 2 years for:

• The reduction of the duration of neutropenia in patients (with non-myeloid malignancy) undergoing myeloablative therapy followed by bone marrow transplantation (BMT) and considered to be at increased risk of prolonged severe neutropenia.
• The reduction of the duration of severe neutropenia and its associated complications in patients undergoing established cytotoxic therapy associated with a significant incidence of febrile neutropenia.
• The mobilization of peripheral blood progenitor cells (PBPCs) for patients as well as healthy donors.

• Lenograstim (rHuG-CSF) 13.4 million International Units (equivalent to 105 micrograms) per ml after reconstitution
• Lenograstim (rHuG-CSF) 33.6 million International Units (equivalent to 263 micrograms) per ml after reconstitution

Lenograstim is the glycosylated recombinant form of human granulocyte colony-stimulating factor. Lenograstim accelerates neutrophil recovery significantly after chemotherapy, with beneficial effects on clinical endpoints such as the incidence of laboratory-confirmed infection and length of hospital stay. Chemotherapy dose intensity has also been increased in patients receiving lenograstim, notably those with breast or small cell lung cancer, although improvements in tumor response and survival have not been demonstrated. Lenograstim also assists neutrophil recovery in patients undergoing bone marrow transplantation and stimulates the production of peripheral blood stem cells (PBSCs) for autologous transfusion after aggressive chemotherapy.

Therapy should only be given in collaboration with an experienced oncology and/or haematology centre.

The recommended dose of Lenograstim is 19.2 MIU (150 µg) per m2 per day, therapeutically equivalent to 0.64 MIU (5 µg) per kg per day for:

• Peripheral Stem Cells or bone marrow transplantation,
• Established cytotoxic chemotherapy
• PBPC mobilisation after chemotherapy.

Lenograstim 13 million IU/mL can be used in patients with body surface area up to 0.7 m2.

Lenograstim 34 million IU/mL can be used in patients with body surface area up to 1.8 m2.

For PBPC mobilisation with Lenograstim alone, the recommended dose is 1.28 MIU (10 µg) per kg per day.

Elderly: Clinical trials with Lenograstim have included a small number of patients up to the age of 70 years but special studies have not been performed in the elderly and therefore specific dosage recommendations cannot be made.

Paediatric Population: The dose in children older than 2 years and adolescent is the same as in adults when used to reduce the duration of neutropenia after myeloablative therapy followed by BMT or after cytotoxic chemotherapy.

Increased risk of myelosuppression with myelosuppressive antineoplastic agents; increased pulmonary toxicity with bleomycin and cyclophosphamide.

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

Lenograstim should not be used to increase the dose intensity of cytotoxic chemotherapy beyond established doses and dosage regimens, since the drug could reduce myelo-toxicity but not the overall toxicity of cytotoxic drugs.

It should not be administered concurrently with cytotoxic chemotherapy. It should not be administered to patients

• with myeloid malignancy other than de novo acute myeloid leukemia,
• with de novo acute myeloid leukemia aged below 55 years, and/or
• with de novo acute myeloid leukemia with good cytogenetics.

Musculoskeletal pain, bone pain, splenic enlargement, nausea, fever, thrombocytopenia, anemia, epistaxis, headache, diarrhea, dysuria, osteoporosis, cutaneous vasculitis, anorexia, Sweet's syndrome, toxic epidermal necrolysis.

There are no adequate data from the use of lenograstim in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Lenograstim should not be used during pregnancy unless clearly necessary. It is unknown whether lenograstim is excreted in human milk. The excretion of lenograstim in milk has not been studied in animals. Breastfeeding should be discontinued during therapy with lenograstim.

This product should be administered only to patients with neutropenia, or to subjects who must have hematopoietic stem cells mobilized into peripheral blood.

During treatment with this product, hematological examinations should be taken periodically to avoid an excessive increase in neutrophil (WBC) count. If an excessive increase in neutrophil (WBC) count is observed, appropriate measures including reducing dosage or discontinuing administration should be taken.

Complete medical histories including histories of allergies and drug hypersensitivity should be taken before initiating therapy with this drug to predict the response of hypersensitivity.

Haematopoietic Agents

Should be stored in a cool and dry place.