INTRODUCTION
GRAFIA R 150IU INJECTION contains Urofollitropin which belongs to the group of medicines called Gonadotropins. It is used in the treatment of female infertility. It can promote ovulation (release of matured egg from the ovaries) in women who do not produce eggs. It also helps in the growth and development of several egg follicles in women undergoing fertility treatments.
Prior to the treatment, your doctor may evaluate your and your partner’s fertility status thoroughly as a precaution. During treatment with GRAFIA R 150IU INJECTION, your doctor will closely monitor your health condition through several blood tests and ultrasounds to avoid the risk of side effects.
Before receiving GRAFIA R 150IU INJECTION inform your doctor if you have any unexplained vaginal bleeding, blood clot problems or any tumours in the brain, breast, uterus or ovaries. You must also inform your doctor if you have any damage in the fallopian tubes, as treatment with GRAFIA R 150IU INJECTION may cause ectopic pregnancy (pregnancy outside of the womb) in such cases.
GRAFIA R 150IU INJECTION should not be used in pregnant women after successful conception. It is also not recommended for use in breastfeeding women and in children or adolescents (aged below 18 years) due to lack of safety data.
The most common side effects of receiving GRAFIA R 150IU INJECTION are hot flushes, stomach pain, headache and injection site reactions (such as pain, redness, and swelling). Consult your doctor if they worsen.
USES OF GRAFIA R 150IU INJECTION
It is used among infertile/anovulatory women to:
- Treat infertility
- Promote ovulation and stimulate the growth and maturation of egg follicles
HOW GRAFIA R 150IU INJECTION WORKS
GRAFIA R 150IU INJECTION is an ovulation stimulator. It supplements your body with a sufficient amount of a female sex hormone called estrogen that is required for the normal growth and development of the ovarian (egg) follicles. As a result, it stimulates egg growth and maturation and promotes the release of matured eggs from the ovaries (ovulation) in women facing problems in becoming pregnant.
DIRECTIONS FOR USE
GRAFIA R 150IU INJECTION will be given to you only by a doctor or a nurse into the muscles (intramuscularly) or under the skin (subcutaneously). It can also be self-administered by the patient if instructed by the doctor. Carefully follow the instructions given by your doctor in case of self-administration.
Your doctor will decide the correct dose and duration of therapy depending upon your age, body weight and disease condition.
SIDE EFFECTS OF GRAFIA R 150IU INJECTION
COMMON
- injection site reactions (pain, redness, itching or swelling)
- headache
- stomach pain, bloated stomach
- urinary tract infection
- inflammation of throat and nasal passage
- hot flushes
- nausea, vomiting, stomach discomfort, diarrhoea, constipation
- skin rash
UNCOMMON
- overactive thyroid gland (hyperthyroidism)
- changes in mood
- feeling tired
- dizziness
- nose bleeds
- breast enlargement and pain
- vaginal bleeding or discharge
RARE
Contact your doctor immediately if you experience any of the following side effects after receiving GRAFIA R 150IU INJECTION:
- signs of ovarian hyperstimulation syndrome (such as lower abdominal pain with sensation of nausea or vomiting, weight gain, difficulty in breathing, difficulty in passing urine, enlarged ovaries and fluid build-up in chest or abdomen)
- signs of allergic reactions (such as skin rash, itching, swelling of the eyes, face, lips, tongue or throat leading to difficulty in breathing or swallowing)
HOW TO MANAGE SIDE EFFECTS
Injection site reactions:
Place an ice pack on the affected area. Do not frequently move the injection site. Consult your doctor if the symptom did not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
Constipation:
Taking GRAFIA R 150IU INJECTION with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.
Nausea and Vomiting
Take GRAFIA R 150IU INJECTION with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your symptom worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
WARNING & PRECAUTIONS
PREGNANCY
GRAFIA R 150IU INJECTION is not recommended for use in pregnant women. Therefore, consult your doctor before receiving it.
BREASTFEEDING
GRAFIA R 150IU INJECTION is not recommended for use in breastfeeding women. Therefore, consult your doctor before receiving it.
DRIVING AND USING MACHINES
GRAFIA R 150IU INJECTION does not affect your ability to drive or operate machinery. However, do not drive or handle any heavy tools or machines if your ability is affected by GRAFIA R 150IU INJECTION.
ALCOHOL
Avoid consumption of alcohol before receiving GRAFIA R 150IU INJECTION.
ALLERGY
Talk to your doctor before receiving GRAFIA R 150IU INJECTION if you are allergic to Urofollitropin.
OTHERS
GRAFIA R 150IU INJECTION is not recommended for use if you:
- have primary ovarian failure (ovaries that do not produce eggs)
- have problems with thyroid, pituitary or adrenal glands
Before receiving GRAFIA R 150IU INJECTION, inform your doctor if you:
- have overactive thyroid gland
- have hyperprolactinemia (high levels of a hormone called prolactin in blood)
- have any tumours in the breasts, uterus, pituitary gland or hypothalamus
- have polycystic ovarian disease or enlarged ovaries
- have any malformation of sex organs that hinders pregnancy
- have undiagnosable vaginal bleeding
- have fibroids in the uterus
- had an early menopause
- have blood clots in the body or have a family history of blood clots
- are overweight
Use in pediatrics:
The safety and effectiveness of GRAFIA R 150IU INJECTION have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor for advice.
Use in geriatrics:
GRAFIA R 150IU INJECTION should be used with caution in elderly patients (aged 65 years or older). Therefore, consult your doctor before receiving it.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving GRAFIA R 150IU INJECTION, inform your doctor if you are taking any of the following medicines:
- Clomiphene citrate (another medicine used in the treatment of female infertility)
Overdosage:
GRAFIA R 150IU 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 | : | Urofollitropin |
| Pharmacological Category | : | Ovulation stimulators |
| Therapeutic Indication | : | Female Infertility |
| Dosage Forms | : | Injection, Pre-filled syringes (PFS), Cartridge |
MORE INFORMATION
- Keep GRAFIA R 150IU INJECTION out of reach of children
- Store GRAFIA R 150IU INJECTION at room temperature
FAQs ABOUT GRAFIA R 150IU INJECTION
What is the use of GRAFIA R 150IU INJECTION?
GRAFIA R 150IU INJECTION is used in the treatment of female infertility. It can promote ovulation (release of matured egg from the ovaries) in women who do not produce eggs. It also helps in the growth and development of several egg follicles in women undergoing fertility treatments.
How GRAFIA R 150IU INJECTION works?
GRAFIA R 150IU INJECTION is an ovulation stimulator. It supplements your body with a sufficient amount of a female sex hormone called estrogen that is required for the normal growth and development of the ovarian (egg) follicles. As a result, it stimulates egg growth and maturation and promotes the release of matured eggs from the ovaries (ovulation) in women facing problems in becoming pregnant.
How GRAFIA R 150IU INJECTION is administered?
GRAFIA R 150IU INJECTION will be given to you only by a doctor or a nurse into the vein (intravenously) or under the skin (subcutaneously). It can also be self-administered by the patients if advised by the physician. Carefully, follow the instructions given by the doctor in case of self-administration.
What precautions must be followed while receiving GRAFIA R 150IU INJECTION?
Before receiving GRAFIA R 150IU INJECTION inform your doctor if you have any unexplained vaginal bleeding, blood clot problems or any tumours in the brain, breast, uterus or ovaries. You must also inform your doctor if you have any damage in the fallopian tubes, as treatment with GRAFIA R 150IU INJECTION may cause ectopic pregnancy (pregnancy outside of the womb) in such cases. GRAFIA R 150IU INJECTION should not be used in pregnant women after successful conception. Regularly visit your doctor and perform all blood tests and ultrasounds recommended by him/her without fail.
Is GRAFIA R 150IU INJECTION safe?
GRAFIA R 150IU INJECTION is considered safe at the doses administered by the physician. However, consult your doctor if you experience any unusual side effects
What are the common side effects of receiving GRAFIA R 150IU INJECTION?
The most common side effects of receiving GRAFIA R 150IU INJECTION are hot flushes, stomach pain, headache and injection site reactions (such as pain, redness, and swelling). Consult your doctor if they worsen.
Can I stop receiving GRAFIA R 150IU INJECTION once my symptoms subside?
Do not stop taking GRAFIA R 150IU INJECTION without consulting your doctor. You need to receive GRAFIA R 150IU INJECTION for the duration recommended by your doctor to achieve better results.
Can I use GRAFIA R 150IU INJECTION during pregnancy?
GRAFIA R 150IU INJECTION should not be used in pregnant women after successful conception. Therefore, consult your doctor for advice.
Can GRAFIA R 150IU INJECTION be used in children?
The safety and effectiveness of GRAFIA R 150IU INJECTION have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor for advice.
REFERENCES
1. KD. Tripathi. Anterior pituitary Hormones. Essentials of Medical Pharmacology. 7th Edition. 2013. Page – 240-241.
2. Andrea Cocci, Gianmartin Cito and others. Effectiveness of highly purified urofollitropin treatment in patients with idiopathic azoospermia before testicular sperm extraction. Urologia Journals. SAGE Journals. [Revised in July 2017]. [Accessed on 7th November 2022] https://journals.sagepub.com/doi/10.5301/uj.5000253
3. Pharmasure Ltd. Revised in June 2016]. [Accessed on 7th November 2022] https://www.pharmasure.co.uk/uploads/uk-PIL-Fostimon-75-150-IU.pdf
4. Ferring Ireland Ltd. Health Products Regulatory Authority. [Revised in April 2016]. [Accessed on 7th November 2022] https://www.hpra.ie/img/uploaded/swedocuments/PIL-2178582-26072016122111-636051324724310000.pdf
5. Bharat Serums and Vaccines Ltd. Foligraf 75 I.U./150 I.U. [Accessed on 7th November 2022] https://bsvgroup.com/assets/pdf/products/Foligraf.pdf
6. Ferring Pharmaceuticals Inc. Bravelle (Urofollitropin for Injection). U.S. Food and Drug Administration. [Revised in February 2014]. [Accessed on 7th November 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf
7. Cipla Ltd. Newmon-R PFSTM injection (Recombinant Human Follicle Stimulating Hormone). [Revised in January 2018]. [Accessed on 7th November 2022] https://ciplamed.com/content/newmon-r-pfstm-injection
USEFUL DIAGNOSTIC TESTS
- Anti-Mullerian Hormone
- Glycosylated Haemoglobin
- Testosterone Total
- Thyroid Stimulating Hormone
PRODUCT DETAILS
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