THERAPEUTIC INDICATIONS

Reduction in the duration of neutropenia and associated complications in patients (with non-myeloid neoplasia) receiving an autologous or allogeneous bone marrow transplantation, Reduction in the duration of neutropenia and associated complications in patients during chemotherapy known to be associated with a significant incidence of febrile neutropenia, and Mobilisation of Peripheral Blood Progenitor Cells (PBPCs).

POSOLOGY AND METHOD OF ADMINISTRATION

The recommended dose of GRANOCYTE 34 is 150 micrograms per m2 and per day, and GRANOCYTE 34 is used in patients with a body surface area of up to 1.8 m2 . Granocyte can be administered by IV infusion lasting 30 minutes, diluted in isotonic saline serum or by subcutaneous injection starting the day following transplantation or after chemotherapy (subcutaneous injection only). Treatment should continue until the expected date of the nadir has passed and the neutrophil count has returned to a stable level compatible with treatment discontinuation, with a maximum of 28 days of treatment if necessary. Specific dose recommendation for elderly cannot be made. The safety and efficacy of GRANOCYTE 34 for children has been established in children older than 2 years in bone marrow transplantation.

CONTRAINDICATIONS

GRANOCYTE 34 is contraindicated in patients with known hypersensitivity to the product or to one of its constituents. Granocyte should not be used to increase the dose intensity of myelotoxic chemotherapy beyond established doses and combinations, administered concurrently with cytotoxic chemotherapy, and administered to patients with myeloid neoplasia other than de novo acute myeloid leukemia, de novo acute myeloid leukemia aged below 55 years, and/or de novo acute myeloid leukemia with good cytogenetics, i.e. t(8; 21), t(15; 17) and inv (16).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

GRANOCYTE 34 should not be used in patients with myelodysplasia syndrome, secondary acute myeloid leukemia or chronic myelogenous leukemia. Special caution is recommended when using GRANOCYTE in any pre-leukemic syndrome situation, because unexpected tumor regrowth may occur during rHuG-CSF therapy. For patients with hyperleukocytosis, if the leukocyte count exceeds 50 x 109 /L after the expected date of the nadir, GRANOCYTE 34 should be discontinued immediately. Cases of venous thromboembolism and arterial thromboembolism have been reported in donors treated with lenograstim. Close monitoring is recommended in donors and patients with known risk factors for thrombosis. GRANOCYTE 34 should not be used to reduce the intervals between chemotherapy courses beyond the established limits, nor to increase the established doses of chemotherapy. Lenograstim should be discontinued if patients develop symptoms of capillary leak syndrome and appropriate symptomatic treatment, which may include a need for intensive care, should be given. Glomerulonephritis has been reported in patients and donors receiving lenograstim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of G-CSF. Urinalysis monitoring is recommended. Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers. The safety and efficacy of GRANOCYTE 34 have not been established in patients with impaired renal or liver function. In patients with decreased bone marrow reserves, for example due to prior intensive chemotherapy/ radiotherapy, neutrophil response is sometimes decreased and the safety of GRANOCYTE 34 has not been established. Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in either healthy donors or patients following administration of Granulocyte-colony stimulating factors (G-CSFs) including lenograstim. Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound). If enlargement of the spleen is observed during lenograstim therapy, appropriate therapeutic measures should be taken including discontinuing administration of the product. A diagnosis of splenic rupture should be considered when left upper abdominal pain or shoulder tip pain is reported.

INTERACTIONS

Use of GRANOCYTE 34 is not recommended during the 24-hours period preceding or following chemotherapy, because of the sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy. Possible interactions with other growth factors of cytokines remain to be determined by clinical trials.

PREGNANCY AND LACTATION

The safety of GRANOCYTE 34 has not been established in pregnant women. During pregnancy, the potential risk of GRANOCYTE 34 to the fetus must be weighed against the expected therapeutic benefit. Treatment with GRANOCYTE 34 is not recommended during lactation, due to the absence of data concerning penetration in the breast milk.

UNDESIRABLE EFFECTS

In Bone Marrow Transplantation, the mean platelet count was lower in patients treated with GRANOCYTE 34 than in those who were given a placebo. In chemotherapy-induced neutropenía, Effects most frequently reported were similar to those seen in patients treated with chemotherapy: alopecia, nausea, vomiting, fever and headache. Common but generally asymptomatic cases of splenomegaly have been reported. Common effect in Blood and lymphatic system is enlarged spleen size. Other undesirable effects such as pulmonary infiltrates, Increase of ASAT, ALAT and/or alkaline phosphatase. Very common : Muscoskeletal pain (include myalgia, arthralgia, etc), headache, asthenia.

OVERDOSE

The effects of Granocyte 34 overdosage have not been established. In humans, doses of up to 40 micrograms per kg per day were not associated with toxic effects, with the exception of bone and muscle pains.

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group : CYTOKINE: granulocyte stimulation factor. LO3AA10.

Presentation

One pack of 1 vial of lyophilized powder (263 µg) + 1 pre-filled syringe of solvent (1 ml). Reg. No. DKI0185600344A1

Manufactured by

Sanofi Winthrop Industrie, Cedex, France

More detailed Information on request:

PT Aventis Pharma

Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210 (021) 4892208 - 4895608

Date of revision: 07-Dec-2021 (Based on BPOM approval 02-May-2019) CCDSv 6, 7, and 8

This information is intended for Health Care Professional only. See local product information for full details information