INTRODUCTION
GRASTIM 300 INJECTION contains Filgrastim which belongs to the group of medicines called Cytokines. GRASTIM 300 INJECTION is used to increase the number of white blood cells to prevent infections after chemotherapy treatment and bone marrow transplant.
GRASTIM 300 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.
GRASTIM 300 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 GRASTIM 300 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.
GRASTIM 300 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 GRASTIM 300 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 GRASTIM 300 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 GRASTIM 300 INJECTION WORKS
GRASTIM 300 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
GRASTIM 300 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 GRASTIM 300 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 GRASTIM 300 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 GRASTIM 300 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 GRASTIM 300 INJECTION. If it lasts more than a week or becomes severe, inform your doctor.
Nausea and vomiting:
Receive GRASTIM 300 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
GRASTIM 300 INJECTION is generally not recommended for use during pregnancy. Consult your doctor before receiving GRASTIM 300 INJECTION.
BREASTFEEDING
GRASTIM 300 INJECTION is generally not recommended for use in breastfeeding women. Consult your doctor before receiving GRASTIM 300 INJECTION.
DRIVING AND USING MACHINES
Do not drive/operate machines if you feel dizzy after receiving GRASTIM 300 INJECTION.
KIDNEY
GRASTIM 300 INJECTION should be used with caution in patients with kidney problems such as renal impairment. Consult your doctor before receiving the medicine.
LIVER
GRASTIM 300 INJECTION should be used with caution in patients with liver problems such as hepatic impairment. Consult your doctor before receiving the medicine.
ALLERGY
GRASTIM 300 INJECTION is not recommended for use if you are allergic (hypersensitive) to Filgrastim, and/or any other ingredients of this medicine.
OTHERS
GRASTIM 300 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 GRASTIM 300 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:
GRASTIM 300 INJECTION should be used with caution in children and adolescents (aged below 18 years). Consult your doctor before GRASTIM 300 INJECTION is administered to the child.
Use in Geriatrics:
GRASTIM 300 INJECTION should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving GRASTIM 300 INJECTION.?
INTERACTIONS
A. Drug-Drug interactions:
Before receiving GRASTIM 300 INJECTION, inform your doctor if you are taking any medicines, including prescription, non-prescription, and/or herbal medicines.
Overdosage:
GRASTIM 300 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 GRASTIM 300 INJECTION out of reach of children
Store GRASTIM 300 INJECTION in a refrigerator between 2-8?C
FAQs ABOUT GRASTIM 300 INJECTION
What is GRASTIM 300 INJECTION used for?
GRASTIM 300 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 GRASTIM 300 INJECTION works?
GRASTIM 300 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 GRASTIM 300 INJECTION?
The most common side effects of receiving GRASTIM 300 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 GRASTIM 300 INJECTION is administered?
GRASTIM 300 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 GRASTIM 300 INJECTION is received more than its required dosage?
GRASTIM 300 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
Country Of Origin
India
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