Biofilgran
Biofilgran Uses, Dosage, Side Effects, Food Interaction and all others data.
Biofilgran is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation, differentiation and enhances phagocytic activity.
Biofilgran is a granulocyte-colony stimulating factor which binds to cell surface receptors on haemetopoietic cells thus stimulating the development of granulocytes to increase their migration and cytotoxicity.
Biofilgran is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow. Biofilgran causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. Elevations of neutrophil counts are dose-dependent at recommended doses. Following termination of Biofilgran therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Biofilgran binds to the G-CSF receptor and stimulates the production of neutrophils in the bone marrow .Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors, in turn, stimulating proliferation and differentiation .
G-CSF and its receptor are necessary for basal and stress-induced granulopoiesis, which forms neutrophils. Mice deficient in G-CSF or G-CSFR have severe neutropenia and reduced levels (~50%) of late-stage neutrophil precursors in the bone marrow under normal, resting conditions .
Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes‚ fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and enhances neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions (including enhanced phagocytic ability‚ priming of the cellular metabolism associated with respiratory burst‚ antibody-dependent killing, and enhanced expression of certain cell surface antigens). G-CSF is not species-specific and has demonstrated to have negligible direct in vivo or in vitro effects on the production or action of hematopoietic cell types other than the neutrophil and its lineage.
| Trade Name | Biofilgran |
| Availability | Prescription only |
| Generic | Filgrastim |
| Filgrastim Other Names | Filgrastim, Filgrastim-aafi, Filgrastim-sndz, G-CSF, Granulocyte Colony Stimulating Factor, Tbo-filgrastim |
| Related Drugs | fluconazole, Diflucan, cisplatin, Neulasta, Zarxio, Neupogen, pegfilgrastim, Udenyca, busulfan, Nivestym |
| Type | |
| Formula | C845H1343N223O243S9 |
| Weight | 18800.0 Da |
| Groups | Approved |
| Therapeutic Class | Haematopoietic Agents |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Biofilgran is used to those:
- Cancer patients receiving myelosuppressive chemotherapy
- Patients with Acute Myeloid Leukemia receiving induction or consolidation chemotherapy
- Cancer patients receiving bone marrow transplant
- Patients with severe neutropenia
- Peripheral blood progenitor cell collection and therapy
Biofilgran is also used to associated treatment for these conditions: Febrile Neutropenia, Hematopoietic Subsyndrome of Acute Radiation Syndrome, Neutropenia, Neutropenia aggravated, Neutropenia-related sequelae, Neutrophil suppression, Severe idiopathic neutropenia, Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
How Biofilgran works
As a G-CSF analog, this drug controls the proliferation of committed progenitor cells and influences their maturation into mature neutrophils. Biofilgran also stimulates the release of neutrophils from bone marrow storage pools and decreases their time to maturation. Biofilgran acts to increase the phagocytic activity of mature neutrophils, thus allowing them to prevent infection. In patients receiving cytotoxic chemotherapy, filgrastim may accelerate neutrophil recovery, leading to a reduction in the duration of the neutropenic phase post chemotherapy .
Used in the treatment of chemotherapy-induced neutropenia by enhancing the production of neutrophils, filgrastim acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. In one efficacy study, levels of neutrophils returned to baseline by 21 days following completion of chemotherapy and the administration of tbo-filgrastim (fast-acting) .
In phase 1 studies involving 96 patients with various non-myeloid malignancies‚ filgrastim administration resulted in a dose-dependent increase in circulating neutrophil counts over the dose range of 1 to 70 mcg/kg/day.
This increase in neutrophil counts was seen whether filgrastim was administered intravenous (1 to 70 mcg/kg twice daily)‚ subcutaneous (1 to 3 mcg/kg once daily)‚ or by continuous subcutaneous (SC) infusion (3 to 11 mcg/kg/day). After the discontinuation of filgrastim therapy‚ neutrophil counts returned to baseline in most cases within only 4 days after Nevistym was used .
Dosage
Biofilgran dosage
Parenteral-
Chemotherapy-induced neutropenia:5 mcg/kg daily as a single daily SC inj, as a continuous IV or SC infusion, or as a daily IV infusion over 15-30 minutes, starting not
Bone marrow transplantation:10 mcg/kg daily by IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr. Adjust according to response.
Subcutaneous-
Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation:10 mcg/kg daily, as a single inj or by continuous infusion, for 4-7 days until the last leucapheresis procedure. If it is given after myelosuppressive chemotherapy: 5 mcg/kg daily by inj; given from the 1st day after chemotherapy completion until expected neutrophil nadir is passed and neutrophil count has returned to normal range, so that leucapheresis can be performed.
Congenital neutropenia:12 mcg/kg daily in single or divided doses. Adjust according to response. In patients with cyclic or idiopathic neutropenia: 5 mcg/kg daily in single or divided doses. Adjust according to response.
HIV infection and persistent neutropenia: Initially, 1 mcg/kg daily. Dose may be increased to 4 mcg/kg daily until normal neutrophil count is achieved. Maintenance: 300 mcg daily. Max: 4 mcg/kg daily.
Dilution of Biofilgran conc less than 5 mcg/ml is not recommended at any time. Biofilgran may be diluted in 5% dextrose as required
Side Effects
Musculoskeletal pain, bone pain, hypersensitivity reactions, splenic enlargement, hepatomegaly, thrombocytopaenia, anaemia, epistaxis, headache, nausea, vomiting, diarrhoea, urinary abnormalities (dysuria, proteinuria, haematuria), osteoporosis, exacerbation of rheumatoid arthritis, transient decrease in blood glucose, raised uric acid, cutaneous vasculitis, transient hypotension.
Toxicity
There are numerous adverse effects associated with Filgastrim. They are organized by organ system as follows:
Generalized effects
Serious allergic reactions, including anaphylaxis: Permanently discontinue NIVESTYM in patients with serious allergic reactions. With non-myeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea . With AML (≥ 2% difference in incidence) are pain, epistaxis and rash . With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia, and alopecia .
Musculoskeletal system
Exacerbation of arthritic symptoms has been uncommonly observed .
Spleen
Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim. Some cases of splenic rupture were fatal .
Respiratory system
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue filgrastim in patients with ARDS . Pulmonary adverse effects, in particular interstitial lung disease, have been reported after G-CSF administration. Patients with a recent history of lung infiltrates or pneumonia may be at higher risk. The onset of pulmonary signs, such as cough, fever and dyspnea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of acute respiratory distress syndrome (ARDS). Biofilgran should be discontinued and appropriate treatment should be given .
Hematological system
Fatal sickle cell crises have occurred.
The granulocyte-colony stimulating factor can promote the malignant growth of myeloid cells in vitro and the same effects may be seen on some non-myeloid cells in vitro. The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukemia have not been established. Biofilgran is not indicated for use in these conditions. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukemia from acute myeloid leukemia .
Capillary leak syndrome has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, edema and hemoconcentration. Patients who show symptoms of capillary leak syndrome must be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care .
Leukocytosis (white blood cell (WBC) > 50 x 109/l) was seen in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim and leukapheresis was observed in 35% of donors .
Renal system
This drug increases the risk of glomerulonephritis. Evaluate and consider dose-reduction or interruption of filgrastim if causality is likely .
Precaution
Biofilgran should not be administered within 24 hours before and after chemotherapy The possibility of Biofilgran acting as a growth factor for any tumor type cannot be excluded. To avoid adverse effects of excessive neutrophils complete blood count is recommended twice per week during treatment. Biofilgran is given by subcutaneous or intravenous infusion as required
Interaction
Drug interactions between Biofilgran and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium should be used with caution.
Food Interaction
No interactions found.Biofilgran Drug Interaction
Moderate: doxorubicin, doxorubicinUnknown: aspirin, aspirin, sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprim, meperidine, meperidine, heparin, heparin, acetaminophen, acetaminophen, vitamin a topical, vitamin a topical, valproic acid, valproic acid, cyanocobalamin, cyanocobalamin, cholecalciferol, cholecalciferol
Biofilgran Disease Interaction
Major: glomerulonephritis, myeloid tumors, leukocytosisModerate: sepsis, thrombocytopenia, sickle cell disease
Volume of Distribution
150 mL/kg
Elimination Route
Absorption and clearance of Neupogen follows first-order pharmacokinetics without concentration dependence. Subcutaneous administration of 3.45 mcg/kg and 11.5 mcg/kg of filgrastim resulted in maximum serum concentrations of 4 and 49 ng/mL‚ respectively‚ within 2-8 hours . Biofilgran does not accumulate. It is estimated that when filgrastim is subcutaneously administered, the absolute bioavailability is approximately 62% and 71% for 375 mcg and 750 mcg doses respectively. When 5 mcg/kg tbo-filgrastim is subcutaneously administered, the absolute bioavailability is 33%. It takes 4-6 hours for tho-filgrastim to reach maximum concentration .
Half Life
Elimination half-life was approximately 3.5 hours in both normal subjects and cancer subjects
Clearance
0.5 - 0.7 mL/minute/kg after SC administration of 3.45 mcg/kg and 11.5 mcg/kg in both normal subjects and cancer patients
Elimination Route
Biofilgran products demonstrate nonlinear pharmacokinetics. The clearance is dependent on filgrastim product concentration in addition to neutrophil count. G-CSF receptor-mediated clearance is saturated by a high concentration of filgrastim products and is diminished by neutropenia. In addition, filgrastim products are cleared by the kidney .
Pregnancy & Breastfeeding use
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindication
Biofilgran is contraindicated in patients hypersensitive to the drug, any ingredient in the formulation, or proteins derived from Escherichia coli.
Special Warning
Pediatric precautions: Biofilgran has been used in children 3 months to 18 years of age without unusual adverse effect. However, safety and efficacy of the drug in neonates or patients with autoimmune neutropenia of infancy have not been established.
Acute Overdose
The possibility of Biofilgran acting as a growth factor for any tumor type and adverse effects of excessive neutrophils may occur in overdose of Biofilgran.
Storage Condition
Refrigerate at 2-8° C. Do not freeze.
Innovators Monograph
You find simplified version here Biofilgran
Biofilgran contains Filgrastim see full prescribing information from innovator Biofilgran Monograph, Biofilgran MSDS, Biofilgran FDA label
FAQ
What is Biofilgran used for?
Biofilgran is used to treat neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony stimulating factor. Biofilgran helps the bone marrow to make new white blood cells. Biofilgran is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause.
How safe is Biofilgran?
Biofilgran is safe for most adults, but should not be taken by people who have known hypersensitivity to E. coli-derived proteins, filgrastim, or any component of Biofilgran.
How does Biofilgran work?
Biofilgran works by helping the body make more neutrophils.
What are the common side effects of Biofilgran?
Common side effects of Biofilgran are include;
- Bleeding gums
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blood in the urine or stools
- bloody nose
- chills
- cough
- coughing up blood
- diarrhea
- difficult or labored breathing
- difficulty with swallowing
- dizziness
- facial swelling
- feeling of fullness
- fever
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nausea
- nosebleeds
- pain in the back, ribs, arms, or legs
- pain spreading to the left shoulder
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red or purple spots on the skin
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- skin rash
- sore throat
- vomiting
- Blurred vision
- chest pain
- nervousness
- pounding in the ears
- slow or fast heartbeat
Is Biofilgran safe during pregnancy?
This Biofilgran should not be used during pregnancy unless the benefit outweighs the risk to the fetus. Risk Summary: Limited published data on use during pregnancy are insufficient to inform a drug-associated risk.
Is Biofilgran safe during breastfeeding?
Some authors recommend withholding breastfeeding for this period of time.
Can I drink alcohol with Biofilgran?
The drinking of alcohol will not affect the safety or usefulness of Biofilgran. is best to use birth control while being treated with Biofilgran.
Can I drive after taking Biofilgran?
Biofilgran may cause dizziness, drowsiness, and tiredness; do not drive or operate heavy machinery if you feel dizzy.
When should be taken of Biofilgran?
Start using the medicine 24 hours or more after you finish your chemotherapy. However, do not use it within 24 hours before you begin another chemotherapy.
How many time can I take Biofilgran daily?
It is usually given once a day, but Biofilgran injection products may be given twice a day when it is used to treat severe chronic neutropenia.
How long does I take Biofilgran?
Biofilgran is given by injection under the skin. For doctors, the treatment plan is to give Biofilgran daily for up to 2 weeks, by subcutaneous injection.
How long do the effects of Biofilgran last?
Biofilgran is a long lasting medicine, with peak levels achieved 24 hours after injection, levels drop considerably over the first 7 days and after 14 days there is only a small amount remaining in the body.
When does Biofilgran start to work?
Biofilgran is designed to automatically start dispensing the Neulasta 27 hours from the time it was applied and it is slowly released over a 45 minute period.
Who should not take Biofilgran?
You should not use Biofilgran if you are allergic to Biofilgran, or to other medicines that contain the E. coli bacteria. Tell your doctor if you have ever had:
- sickle cell disorder;
- kidney disease;
- latex allergy; or
- radiation treatment.
Tell your doctor if you are pregnant or breastfeeding.
What happens if I miss a dose?
If you miss a dose of Biofilgran, inject it as soon as you can if it is within 12 hours of the missed dose. If it is over 12 hours since your missed dose, skip the missed dose and go back to your usual dosing schedule. Do not inject twice within the same day.
Can I overdose on Biofilgran?
If you take too much Biofilgran, call your local Poison Control Center or seek emergency medical attention right away.
Can I stop taking Biofilgran?
Do not stop using Biofilgran injection products without talking to your doctor. Biofilgran injection products may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication under the skin at home.
Can Biofilgran affect my kidneys?
Biofilgran may cause GN that can be severe enough to cause AKI requiring dialysis; however, the course is usually self-limited.
Can Biofilgran affects my liver?
Biofilgran has not been described as a cause of drug-induced liver injury.
Can Biofilgran cause leukemia?
This Biofilgran may cause blood or bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer.
