INTRODUCTION
GRAFEEL 300MCG INJECTION contains Filgrastim which belongs to the group of medicines called Cytokines. GRAFEEL 300MCG INJECTION is used to increase the number of white blood cells to prevent infections after chemotherapy treatment and bone marrow transplant.
GRAFEEL 300MCG INJECTION is also used before high-dose chemotherapy to make the bone marrow produce more stem cells after treatment. It is also used to prevent infections in patients suffering from severe chronic neutropenia (rare blood disorder marked by abnormal white blood cell levels).? The medicine is also indicated for use to reduce the risk of infections in patients with advanced HIV infection.
GRAFEEL 300MCG INJECTION is not recommended for use in patients allergic to Filgrastim. It is also not recommended for use in patients suffering from hereditary fructose intolerance (rare genetic disorder marked by inability of the body to break down fructose).
Before receiving GRAFEEL 300MCG INJECTION, inform your doctor if you suffer from sickle cell anemia (inherited blood disorder), osteoporosis (condition marked by weak and gentle bones), and/or have kidney/liver problems.
GRAFEEL 300MCG INJECTION is generally not recommended for use in pregnant and breastfeeding women. It should be used with caution in children and adolescents (aged below 18 years) and in elderly patients (aged 65 years and above) after consulting the doctor.
The most common side effects of receiving GRAFEEL 300MCG INJECTION are anemia, headache, decreased appetite, nausea, vomiting, constipation, diarrhea, and/or unusual hair loss. Consult your doctor if any of these symptoms worsens.
USES OF GRAFEEL 300MCG INJECTION

Increases white blood cell count after chemotherapy treatment and bone marrow transplant to prevent infections in affected individuals

Prevents infections in patients suffering from severe chronic neutropenia

Helps to reduce risk of infections in patients with advanced HIV infection

HOW GRAFEEL 300MCG INJECTION WORKS
GRAFEEL 300MCG INJECTION works by stimulating the bone marrow to produce more neutrophils (type of white blood cell) which helps in fighting the microorganisms and prevent the occurrence of infection after chemotherapy/bone marrow transplant in affected individuals.
DIRECTIONS FOR USE
GRAFEEL 300MCG INJECTION will be given to you only by a doctor or a nurse into the skin as a subcutaneous injection or into the vein as an intravenous infusion. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF GRAFEEL 300MCG INJECTION

COMMON

Thrombocytopenia (reduced ability of blood to clot)

Anemia

Headache

Decreased appetite, nausea, vomiting, constipation, diarrhea

Unusual hair loss/thinning

Pain, general weakness/feeling unwell, tiredness, fever, muscle spasm

Mucosal inflammation (soreness and swelling of the digestive tract)

Signs of bronchitis (inflammation of the lung) such as cough, shortness of breath, chest discomfort

Oral pain, nose bleeds, upper respiratory tract infection, chest pain

Urinary tract infection

Sleeplessness, dizziness

Hypoesthesia (decreased feeling of sensitivity especially in the skin)

Tingling/numbness and swelling in hands and feet

Low/high blood pressure

Cough

Pain in mouth and throat

Rash, redness of skin

Dysuria (pain when passing urine)

UNCOMMON

Allergic reaction (hypersensitivity)

Rejection of transplanted bone marrow

Liver damage caused by blocking of the small veins within the liver

Respiratory failure (impaired lung function) causing breathlessness

Pulmonary oedema (swelling and/or fluid in the lungs)

Inflammation of the lungs

Bleeding from the lung (pulmonary haemorrhage)

Hypoxia (lack of absorption of oxygen in the lung)

Bumpy skin rash (rash maculo-papular)

Osteoporosis (disease which causes bones to become less dense, making them weaker, more brittle and likely to break)

Injection site reaction

RARE

Signs of sickle cell anemia such as severe pain in the bones, chest, gut, and/or joints

Anaphylactic reaction (sudden life-threatening allergic reaction)

Pseudogout (pain and swelling of the joints)

Fluid volume disturbances

Cutaneous vasculitis (inflammation of the blood vessels in the skin)

Plum-colored, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)

Worsening of rheumatoid arthritis (joint inflammation)

Inflammation of aorta
Stop receiving GRAFEEL 300MCG INJECTION and contact your doctor immediately if you experience any of the following side effects:
Signs of an allergic reaction such as weakness, drop in blood pressure, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, shortness of breath, red itchy welts, and/or rash

Signs of acute respiratory distress syndrome (condition that occurs due to accumulation of fluid in air sacs) such as cough, fever, and/or difficulty in breathing (dyspnoea)

Signs of glomerulonephritis (kidney injury) such as puffiness in your face/ankles, blood in urine/brown-coloured urine, and/or low urine output

Signs of capillary leak syndrome (condition that occurs due to blood leakage from small blood vessels into body) such as swelling/puffiness associated with low urine output, difficulty breathing, abdominal swelling, feeling of fullness, and/or general feeling of tiredness

Signs of sepsis (blood poisoning) such as fever, shivering, feeling very cold, high heart rate, confusion/disorientation, shortness of breath, extreme pain/discomfort, and/or clammy/sweaty skin

Enlarged/ruptured spleen associated with symptoms such as left abdominal pain, pain below the left rib cage, and/or pain at the tip of shoulder

Blood in urine (haematuria)

Signs of thrombocytopenia (decreased blood platelet count) such as unusual bleeding/bruising

Signs of aortitis (inflammation of aorta) such as fever, abdominal pain, malaise, and/or back pain

HOW TO MANAGE SIDE EFFECTS
Headache:
If GRAFEEL 300MCG INJECTION causes headache, then take rest and drink plenty of fluids. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of receiving GRAFEEL 300MCG INJECTION. If it lasts more than a week or becomes severe, inform your doctor.
Nausea and vomiting:
Receive GRAFEEL 300MCG INJECTION with or just after a meal. Stick to simple meals. Avoid eating oil rich or spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, drink slowly in between meals. Inform your doctor if the condition worsens.
Constipation:
Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Involve in regular exercise such as going for a daily walk or run). If this does not help, consult and inform your doctor for receiving alternate treatments for constipation.
Diarrhoea:
Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult and inform your doctor if the symptom worsens.
WARNING & PRECAUTIONS

PREGNANCY
GRAFEEL 300MCG INJECTION is generally not recommended for use during pregnancy. Consult your doctor before receiving GRAFEEL 300MCG INJECTION.
BREASTFEEDING
GRAFEEL 300MCG INJECTION is generally not recommended for use in breastfeeding women. Consult your doctor before receiving GRAFEEL 300MCG INJECTION.
DRIVING AND USING MACHINES
Do not drive/operate machines if you feel dizzy after receiving GRAFEEL 300MCG INJECTION.
KIDNEY
GRAFEEL 300MCG INJECTION should be used with caution in patients with kidney problems such as renal impairment. Consult your doctor before receiving the medicine.
LIVER
GRAFEEL 300MCG INJECTION should be used with caution in patients with liver problems such as hepatic impairment. Consult your doctor before receiving the medicine.
ALLERGY
GRAFEEL 300MCG INJECTION is not recommended for use if you are allergic (hypersensitive) to Filgrastim, and/or any other ingredients of this medicine.
OTHERS
GRAFEEL 300MCG INJECTION is not recommended if you:
Suffer from hereditary fructose intolerance (rare genetic disorder marked by inability of the body to break down fructose)
Before receiving GRAFEEL 300MCG INJECTION, inform your doctor if you:
Have sickle cell anemia (inherited blood disorder)

Suffer from osteoporosis (condition marked by weak and gentle bones)

Are a stem cell donor
Use in Pediatrics:
GRAFEEL 300MCG INJECTION should be used with caution in children and adolescents (aged below 18 years). Consult your doctor before GRAFEEL 300MCG INJECTION is administered to the child.
Use in Geriatrics:
GRAFEEL 300MCG INJECTION should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving GRAFEEL 300MCG INJECTION.?
INTERACTIONS
A. Drug-Drug interactions:
Before receiving GRAFEEL 300MCG INJECTION, inform your doctor if you are taking any medicines, including prescription, non-prescription, and/or herbal medicines.
Overdosage:
GRAFEEL 300MCG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms. ?
SYNOPSIS

Drug :?? Filgrastim

Pharmacological Category :?? Cytokine

Therapeutic Indication :?? Prevents infections after chemotherapy treatment and bone marrow transplant, Prevents infections from severe chronic neutropenia, helps to reduce risk of infections in advanced HIV?patients

?? ? ? ??

Dosage Forms :?? Injection, Pre-filled syringe

MORE INFORMATION

Keep GRAFEEL 300MCG INJECTION out of reach of children

Store GRAFEEL 300MCG INJECTION in a refrigerator between 2-8?C

FAQs ABOUT GRAFEEL 300MCG INJECTION
What is GRAFEEL 300MCG INJECTION used for?
GRAFEEL 300MCG INJECTION is used to prevent infections after chemotherapy treatment and bone marrow transplant. It is also used to prevent infections in patients suffering from severe chronic neutropenia (rare blood disorder marked by abnormal white blood cell levels).? The medicine is also indicated for use to reduce the risk of infections in patients with advanced HIV infection.
How GRAFEEL 300MCG INJECTION works?
GRAFEEL 300MCG INJECTION works by stimulating the bone marrow to produce more neutrophils (type of white blood cell) which helps in fighting the microorganisms and prevent the occurrence of infection after chemotherapy/bone marrow transplant in affected individuals.
What are the side-effects of GRAFEEL 300MCG INJECTION?
The most common side effects of receiving GRAFEEL 300MCG INJECTION are anemia, headache, decreased appetite, nausea, vomiting, constipation, diarrhea, and/or unusual hair loss. Consult your doctor if any of these symptoms worsens.
How GRAFEEL 300MCG INJECTION is administered?
GRAFEEL 300MCG INJECTION will be given to you only by a doctor or a nurse into the skin as a subcutaneous injection or into the vein as an intravenous infusion. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
What happens if GRAFEEL 300MCG INJECTION is received more than its required dosage?
GRAFEEL 300MCG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms. ?
REFERENCES
1. Theresa A. Neumann, MaryAnn Foote. The Safety Profile of Filgrastim and Pegfilgrastim. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. 2012. [Accessed on 1st December 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122905/
2. Kamel Laribi, Delphine Badinand, Philippe Janoray, Khaled Benabed, Jean-Loup Mouysset, Elizabeth Fabre, Fran?oise Monchecourt, Rafik Diab. Filgrastim prophylaxis in elderly cancer patients in the real-life setting: a French multicenter observational study, the TULIP study. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. 2019. [Accessed on 1st December 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803566
3.?Amgen Technology (Ireland) Unlimited Company. Electronic Medicines Compendium (EMC) [Revised in July 2022] [Accessed on 1st December 2022]?https://www.medicines.org.uk/emc/files/pil.3000.pdf
USEFUL DIAGNOSTIC TESTS

Complete Blood Count

Peripheral Smear Examination

PRODUCT DETAILS

Net Qty

1 N

Ingredient

FILGRASTIM 300MCG

Hsn Code

30029090

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