INTRODUCTION

FERASIRO 360 TABLET contains Deferasirox, which belongs to the group of medicines called Iron chelators. FERASIRO 360 TABLET is used to remove chronic iron overload (excess iron in the body) caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.

FERASIRO 360 TABLET is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major and other types of anaemia with iron overload caused by repeated blood transfusions and in children 2 to 5 years of age.

FERASIRO 360 TABLET is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with non-transfusion-dependent thalassaemia syndromes.

Your doctor may advise you to undergo relevant tests to analyse your existing condition and monitor your kidney and liver function during treatment.

FERASIRO 360 TABLET is not recommended for use in patients with moderate to severe kidney disease, severe liver disease, advanced stage of myelodysplastic syndrome (decreased production of blood cells by the bone marrow) or advanced stage of cancer.

FERASIRO 360 TABLET inform your doctor if you have heart disease. FERASIRO 360 TABLET is generally not recommended for use by pregnant and breastfeeding women, unless recommended by your doctor. FERASIRO 360 TABLET is not recommended for use in children under 2 years of age.

The most common side effects of taking FERASIRO 360 TABLET are nausea, vomiting, diarrhoea, abdominal pain, bloating, constipation, indigestion, rash, itching, headache, and change in liver or kidney function tests or urine tests. Consult your physician if any of your symptoms get worse or persist.

USES OF FERASIRO 360 TABLET

• Treats chronic iron overload (excess iron in the body) caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older
• Treats chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major and other types of anaemia with iron overload caused by repeated blood transfusions and in children 2 to 5 years of age
• Used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with non-transfusion-dependent thalassaemia syndromes

HOW FERASIRO 360 TABLET WORKS

FERASIRO 360 TABLET works by trapping and removing excess iron from the body, which is then excreted mainly in the form of stools and reduces the risk of organ damage to the liver and heart. As a result, FERASIRO 360 TABLET helps to remove excess iron from the body.

DIRECTIONS FOR USE

Take FERASIRO 360 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your physician will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.

SIDE EFFECTS OF FERASIRO 360 TABLET

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a pain-relieving balm on the head if necessary. Contact your doctor if your headache does not improve.

Nausea and vomiting:

Take the medicine with or just after a meal. Stick to simple meals. Avoid eating oily or spicy foods. Contact your doctor if your symptoms do not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices, to keep yourself hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if your symptoms do not improve.

Stomach pain:

Try to rest and relax. Eat small meals but take them frequently. Keep a heating pad on your stomach if needed. Contact your doctor if your symptoms do not improve.

Constipation:

Eat fiber-rich foods such as fresh fruits, vegetables, and cereals. Drink lots of water and exercise more regularly. Contact your doctor if your symptoms do not improve.

Dizziness or drowsiness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if your symptoms do not improve.

Indigestion:

Eat small meals but take them frequently. Eat and exercise regularly. Contact your doctor if your symptoms do not improve.

Itchy skin:

Avoid hot showers because hot water can irritate the skin. Do not scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if your symptoms do not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking FERASIRO 360 TABLET inform your doctor if you are taking any of the following medicine:

• iron chelators Ex.  deferiprone (medicines used in iron overload)
• aluminium-containing antacids (medicines used to treat heartburn)
• cyclosporin (used to prevent the rejection of the transplanted organ and treats other conditions, such as rheumatoid arthritis or atopic dermatitis)
• painkillers or anti-inflammatory medicines (ex. aspirin, ibuprofen, corticosteroids like fluticasone)
• oral bisphosphonates (medicines used to treat osteoporosis)
• warfarin (medicines used to prevent or treat blood clots)
• hormonal contraceptive agents (medicines used to prevent pregnancy)
• bepridil (medicines used to treat heart problems)
• eletriptan, dihydroergotamine, ergotamine (medicines used for migraines)
• repaglinide (used to treat diabetes)
• rifampicin (used to treat tuberculosis)
• phenytoin, phenobarbital, carbamazepine (used to treat epilepsy)
• paclitaxel (medicines used to treat cancer)
• theophylline (used to treat asthma)
• tizanidine (medicines used to relax muscle)
• bile acid sequestrants like cholestyramine, colesevelam, colestipol) (medicines used to lower cholesterol levels)
• busulfan (used in bone marrow transplantation)
• midazolam (medicines used to treat anxiety and insomnia)
• alfentanil (medicines used in anaesthesia)
• aprepitant (medicines used to prevent nausea and vomiting after chemotherapy)
• budesonide (medicines used to treat asthma)
• buspirone (medicines used to treat anxiety)
• conivaptan, tolvaptan (medicines used to treat low sodium levels)
• darifenacin (medicines used to treat overactive bladder)
• darunavir, ritonavir, indinavir, lopinavir, maraviroc, saquinavir, tipranavir (medicines used to treat HIV infection)
• dasatinib (medicines used to treat chronic myeloid leukaemia)
• dronedarone, quinidine (medicines used to treat heart rhythm disorders)
• eplerenone (medicines used to treat heart failure)
• everolimus, sirolimus, tacrolimus (medicines used to prevent rejection of transplant organ)
• felodipine, nisoldipine (medicines used to treat high blood pressure)
• fentanyl (medicines used to treat severe pain)
• lovastatin, simvastatin (medicines used to lower cholesterol levels)
• lurasidone, quetiapine, clozapine (medicines used to treat schizophrenia)
• pimozide (used to treat motor or verbal tics)
• sildenafil, vardenafil (medicines used for erectile dysfunction)
• triazolam (medicines used to treat insomnia)
• ticagrelor (medicines used to prevent blood clots)
• alosetron (medicines used to treat irritable bowel syndrome)
• caffeine (medicines used to treat wakefulness, headache, migraine)
• duloxetine (a medicine used to treat depression)
• melatonin, ramelteon (medicines used to treat sleep problems)
• tacrine (medicines used to treat Alzheimer’s disease)

Overdosage:

If you or anyone else accidentally have taken too much of FERASIRO 360 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are nausea, vomiting, abdominal pain, diarrhoea, and kidney or liver problems.

SYNOPSIS

MORE INFORMATION

• Keep FERASIRO 360 TABLET out of the sight and reach of children
• Store FERASIRO 360 TABLET below 30°C

FAQs ABOUT FERASIRO 360 TABLET

How does FERASIRO 360 TABLET work?

FERASIRO 360 TABLET works by trapping and removing excess iron from the body, which is then excreted mainly in the form of stools and reduces the risk of organ damage to the liver and heart.

What are the side effects of taking FERASIRO 360 TABLET?

The most common side effects of taking FERASIRO 360 TABLET are nausea, vomiting, diarrhoea, abdominal pain, bloating, constipation, indigestion, rash, itching, headache, and change in liver or kidney function tests or urine tests. Contact your physician if any of the symptoms worsen.

Who should not take FERASIRO 360 TABLET?

FERASIRO 360 TABLET should not be used if you are allergic to this medicine or by pregnant or breastfeeding women, people with severe liver disease, moderate to severe kidney disease, advanced stage myelodysplastic syndrome, advanced cancer, poor performance status, or severe thrombocytopenia. Contact your doctor before taking FERASIRO 360 TABLET.

Does FERASIRO 360 TABLET cause liver damage?

Yes. FERASIRO 360 TABLET may cause liver damage. If you experience any unusual symptoms such as drowsiness, upper right abdominal pain, yellowish discoloration of the skin or whites of the eyes (jaundice), or dark urine, stop taking FERASIRO 360 TABLET and contact your doctor.

Does FERASIRO 360 TABLET cause vision loss?

Yes. FERASIRO 360 TABLET may cause partial vision loss. Stop taking FERASIRO 360 TABLET and contact your doctor if you experience any unusual symptoms like blurred or cloudy eyes.

REFERENCES

1. Laurence L. Brunton, Randa Hilal-Dandan, Bjorn C Kollmann. Environmental toxicology: carcinogens and heavy metals. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. 2018. Page – 1313.

2. Ali Taher, Amal El-Beshlawy, Mohsen S Elalfy, Kusai Al Zir, Shahina Daar, Dany Habr, Ulrike Kriemler-Krahn, Abdel Hmissi, and Abdullah Al Jefri. Uses of Deferasirox. National Institute of Health. NIH National Centre for Biotechnology Information. Pubmed.gov. June 2009. [Accessed on 20th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730551/

3. Novartis Pharmaceuticals UK Ltd. Electronic Medicines Compendium (EMC). [Revised in March 2021] [Accessed on 20th June 2022] https://www.medicines.org.uk/emc/files/pil.4329.pdf

4. Mylan Pharmaceuticals Limited. European Medical Agency (EMA). [Revised in September 2019] [Accessed on 20th June 2022] https://www.ema.europa.eu/en/documents/product-information/deferasirox-mylan-epar-product-information_en.pdf

5. Novartis Pharma Stein AG. U.S. Food & Drug Administration. [Revised in October 2013] [Accessed on 20th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf

6. Deferasirox. Accord Healthcare Polska Sp.z.o.o. [Revised in December 2021 [Accessed on 20th June 2022] https://cdn.accord-healthcare.com/ie/public/pil/eu_deferasirox_accord_ema-combined-h-5156-en-ib04_version4_-_pil_0.pdf

7. Zydus Pharmaceuticals (USA) Inc. Deferasirox. [Revised in August 2021 [Accessed on 20th June 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c

USEFUL DIAGNOSTIC TESTS

• Serum ferritin, Iron studies, Total Iron Binding Capacities
• Complete blood count
• Liver function test
• Kidney function test
• Urine test