Carboplatin and Filgrastim, Tbo-filgrastim

• Generic Name: carboplatin
• Dosage Forms: n.a.
• Other Brand Names: Paraplatin, CARBOplatin Novaplus

Carboplatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Carboplatin is used together with other cancer medications to treat ovarian cancer.

Carboplatin may also be used for purposes not listed in this medication guide.

• Generic Name: filgrastim
• Dosage Forms: n.a.
• Other Brand Names: Neupogen, Neupogen SingleJect, Nivestym, Zarxio

Management of cancer chemotherapy-induced neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive antineoplastic therapies associated with a clinically important risk of febrile neutropenia; in clinical studies, filgrastim reduced risk of infectious complications (as manifested by febrile neutropenia) and tbo-filgrastim reduced duration of severe neutropenia.

Based on demonstration of biosimilarity, no clinically meaningful differences considered to exist between filgrastim-sndz and filgrastim with respect to efficacy.

Current guidelines for the use of colony-stimulating factors (CSFs) in adults with solid tumors or nonmyeloid malignancies (e.g., lymphoma) recommend prophylaxis with CSFs based upon a patient's risk of developing febrile neutropenia following chemotherapy, taking into account the type of cancer, chemotherapy regimen, patient risk factors, and treatment intent. Prophylaxis recommended for adults with these malignancies who are at high risk of febrile neutropenia (> 20%) and can be considered for patients at intermediate risk (10–20%) if risk is due to patient risk factors and not the chemotherapy regimen. Prophylaxis is generally not recommended in patients with a low risk of febrile neutropenia (<10%).

Secondary prophylaxis with CSFs recommended in patients who had a neutropenic complication from a previous chemotherapy cycle (for which primary prophylaxis not received) and in whom a reduced chemotherapy dose or treatment delay would compromise disease-free or overall survival or treatment outcomes.

Efficacy not established in patients receiving antineoplastic therapy associated with delayed myelosuppression (e.g., nitrosourea derivatives) or in those receiving mitomycin or myelosuppressive doses of antimetabolites (e.g., cytarabine, fluorouracil).

Filgrastim has been used in conjunction with empiric anti-infective therapy for the treatment of chemotherapy-induced febrile neutropenia.

Guidelines recommend that patients who develop febrile neutropenia despite receiving prophylactic treatment with CSFs should continue receiving treatment with the same CSF. CSFs should not be routinely used as adjunctive treatment with antibiotic therapy for patients with fever and neutropenia. CSF therapy may be considered for patients who did not receive prophylaxis and develop febrile neutropenia if risk factors for infection-related complications or poor outcomes are present (e.g., patients >65 years of age, sepsis syndrome, ANC <100/mm3, anticipated or prolonged neutropenia [>10 days], pneumonia, invasive fungal infections or other clinically documented infections, hospitalization, prior episodes of febrile neutropenia).

Leukemia (Filgrastim or Filgrastim-sndz)

Reduction of the time to neutrophil recovery and the duration of fever following induction or consolidation cancer chemotherapy in adults with acute myeloid leukemia (AML); filgrastim designated an orphan drug by FDA for the reduction in duration of neutropenia, fever, antibiotic use, and hospitalization following induction and consolidation treatment for AML.

Use of filgrastim in patients with acute leukemia has been controversial, since results of in vitro studies indicate that certain leukemic cell lines have receptors for G-CSF and that the survival, proliferation, and differentiation of the cells are supported by CSFs. Some experts state that use of filgrastim in the treatment of myeloid leukemia should be considered investigational and undertaken with caution.

Some guidelines state use of CSFs may be considered in patients with AML during induction therapy for patients who are septic and have a life-threatening infection in an attempt to shorten the duration of neutropenia. Data lacking on whether growth factors have a positive or negative impact on long-term outcome if used during consolidation therapy. Growth factors not routinely recommended in post-remission therapy, except in life-threatening infections or when manifestations of sepsis are present and leukemia is in remission.

Autologous and Allogeneic Bone Marrow Transplantation (BMT) (Filgrastim or Filgrastim-sndz)

Reduction of the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative cancer chemotherapy followed by BMT; filgrastim designated an orphan drug by FDA for the treatment of neutropenia associated with BMT.

Peripheral Blood Progenitor Cell (PBPC) Transplantation (Filgrastim or Filgrastim-sndz)

Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; filgrastim designated an orphan drug by FDA for mobilization of PBPC for collection in patients who will receive myeloablative or myelosuppressive cancer chemotherapy.

Also used for acceleration of myeloid engraftment following autologous PBPC transplantation.

Congenital, Cyclic, and Idiopathic Neutropenias (Filgrastim or Filgrastim-sndz)

Reduction of the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or acquired idiopathic neutropenia; filgrastim designated an orphan drug by FDA for treatment of severe chronic neutropenia (ANC <500/m3).

Initiate therapy in patients with severe chronic neutropenia only after a diagnosis of congenital, cyclic, or idiopathic neutropenia has been confirmed and other diseases associated with neutropenia have been excluded.

Hematopoietic Syndrome of Acute Radiation Syndrome (Filgrastim)

Increase survival in patients acutely exposed to myelosuppressive doses of radiation; designated an orphan drug by FDA for treatment of patients at risk of developing myelosuppression after a radiologic or nuclear incident.

Myelodysplastic Syndromes and Aplastic Anemia (Filgrastim)

Has been used to increase leukocyte counts in adults with myelodysplastic syndrome (MDS) classified as refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), or refractory anemia with excess blasts in transformation (RAEB-T); however, it is unclear whether filgrastim will alter (either increase or decrease) the rate of progression to acute myeloid leukemia or alter the usually fatal outcome of the disease. Designated an orphan drug by FDA for treatment of MDS. Safety and efficacy for this use not established; use generally should be limited to experts in such therapy.

Has been used with some success to increase leukocyte counts in a limited number of children 1–17 years of age with moderate to severe aplastic anemia. Use generally should be limited to experts in such therapy.

Neutropenia Associated with HIV Infection and Antiretroviral Therapy (Filgrastim)

Treatment to correct or minimize HIV-associated neutropenia and/or drug-induced neutropenia.

Treatment, alone or in conjunction with epoetin alfa, to ameliorate the hematologic toxicity (severe anemia and/or granulocytopenia) associated with zidovudine therapy in adults with AIDS or AIDS-related complex (ARC).

Filgrastim designated an orphan drug by FDA for the treatment of HIV-infected patients who, in addition, are afflicted with cytomegalovirus retinitis and are being treated with ganciclovir.