INTRODUCTION

PHOSMID 500MG INJECTION contains Cyclophosphamide, which belongs to a group of medicines called Alkylating agents. It is used in the treatment of malignant diseases in adults and children such as malignant lymphomas (Stages III and IV), Hodgkin’s disease, Non-Hodgkin’s lymphoma, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma, multiple myeloma, chronic lymphocytic leukemia, chronic granulocytic leukemia, acute myelogenous leukemia, monocytic leukemia and acute lymphoblastic leukemia, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, Ewing’s sarcoma, breast cancer.

PHOSMID 500MG INJECTION is also indicated for the treatment of nephrotic syndrome in children who fail to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. PHOSMID 500MG INJECTION is not recommended for use in patients with acute infections, bone-marrow aplasia and urinary tract infections like cystitis, acute urothelial toxicity from cytotoxic chemotherapy or radiation therapy or urinary outflow obstruction.

Before receiving PHOSMID 500MG INJECTION, inform your doctor if you have had allergic or anaphylactic reactions to other alkylating agents; bone marrow suppression or failure, including leukopenia, neutropenia, thrombocytopenia and anaemia, neutropenic fever, serious infections include pneumonias, bacterial, fungal, viral, protozoal and parasitic infections, severe immune suppression, concomitant chemotherapy and/or radiation therapy, urinary tract and renal diseases like haemorrhagic cystitis, pyelitis, urethritis and haematuria, urotoxicity such as bladder ulceration, necrosis, fibrosis, contracture, urinary tract obstructions or active urinary tract infections, nephrotoxicity, including renal tubular necrosis, heart diseases such as myocarditis, myopericarditis, pericardial effusion including cardiac tamponade and congestive heart failure, ventricular arrhythmias (including atrial fibrillation, flutter, severe QT prolongation with ventricular tachyarrhythmia), pneumonitis, pulmonary fibrosis, pulmonary veno-occlusive disease, respiratory failure, pneumonitis and secondary malignancies (urinary tract cancer, myelodysplasia, acute leukaemia’s, lymphomas, thyroid cancer, sarcomas and bladder cancer), veno-occlusive liver disease, poor wound healing, hyponatremia and syndrome of inappropriate secretion of antidiuretic hormone.

PHOSMID 500MG INJECTION is not recommended for use by pregnant women. PHOSMID 500MG INJECTION is generally not recommended for use in breastfeeding women as it may pass through the breast milk. PHOSMID 500MG INJECTION should be used with caution in children and the elderly. The most common side effects of receiving PHOSMID 500MG INJECTION are nausea, vomiting, weight loss, alopecia, hematuria and leukopenia. Contact your doctor if any of your symptoms get worse or persist.

USES OF PHOSMID 500MG INJECTION

Treats malignant diseases such as:

• malignant lymphomas (Stages III and IV)
• Hodgkin’s disease, non-Hodgkin’s lymphoma
• lymphocytic lymphoma (nodular or diffuse)
• mixed-cell type lymphoma
• histiocytic lymphoma
• Burkitt’s lymphoma
• multiple myeloma
• chronic lymphocytic leukaemia, chronic granulocytic leukaemia
• acute myelogenous leukemia, monocytic leukemia and acute lymphoblastic leukaemia
• mycosis fungoides
• neuroblastoma
• adenocarcinoma of the ovary
• retinoblastoma
• Ewing’s sarcoma
• breast cancer
• nephrotic syndrome in paediatrics patients

HOW PHOSMID 500MG INJECTION WORKS

PHOSMID 500MG INJECTION works by interfering with the malignant cell growth by cross-linking of cancer cells’ DNA. PHOSMID 500MG INJECTION also transfers alkyl groups to DNA during the process of cell division, thus preventing the normal synthesis of DNA. Therefore, stopping the growth and multiplication of cancer cells.

DIRECTIONS FOR USE

PHOSMID 500MG INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous injection or infusion. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF PHOSMID 500MG INJECTION

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. Do not consume alcohol. Contact your doctor if the symptom does not improve.

Nausea and vomiting:

Receive the medicine, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if the symptom does not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not take any medicine on your own for treating diarrhea. Contact your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before receiving PHOSMID 500MG INJECTION, inform your doctor if you are receiving any of the following medicine:

• medicines used to treat cancer (Ex. paclitaxel)
• depolarizing muscle relaxants Ex. succinylcholine (a medicine used in anaesthesia)
• aprepitant (medicines used to prevent being sick)
• busulfan, thiotepa (medicines used to treat cancer)
• ciprofloxacin, chloramphenicol, sulfadiazine, sulfasalazine, sulfamethoxazole (medicines used to treat bacterial infections)
• fluconazole, itraconazole (used for fungal infections)
• prasugrel (medicines used to thin the blood)
• allopurinol (medicines used to treat gout)
• azathioprine (medicines used to reduce the activity of the immune system)
• chloral hydrate (medicines used to treat insomnia)
• Cimetidine (for treating stomach ulcers)
• disulfiram (medicines used to treat alcoholism)
• glyceraldehyde (medicines used to treat warts)
• protease inhibitors Ex. atazanavir, darunavir (medicines used to treat viruses)
• ondansetron (medicines used to prevent being sick)
• rifampin (medicines used to treat bacterial infections)
• medicines used to treat epilepsy or seizures (Ex. carbamazepine, phenobarbital, phenytoin)
• St. John’s wort (used for depression)
• corticosteroids (medicines used for inflammation)
• other anti-cancer medicines Ex. cisplatin, carboplatin etc. (medicines used to treat cancer)
• carbimazole (medicines used to treat an overactive thyroid)
• zidovudine (medicines used to treat viruses)
• medicines used to treat multiple sclerosis Ex. natalizumab
• medicines used to treat high blood pressure (ACE inhibitors like enalapril, thiazide diuretics such as hydrochlorothiazide or chlorthalidone)
• anthracyclines Ex. bleomycin, doxorubicin, epirubicin, mitomycin (used to treat cancer) - cytarabine, pentostatin, trastuzumab (medicines used to treat cancer)
• amiodarone (medicines used to treat irregular heartbeat)
• medicines used to increase white blood cell numbers after chemotherapy (Ex. GM-CSF, G-CSF)
• amphotericin-B (used for fungal infections)
• medicines used to treat pain and inflammation (Ex. indomethacin)
• etanercept (medicines used to treat rheumatoid arthritis)
• metronidazole (medicines used to treat bacterial or protozoal infections)
• medicines used to treat breast cancer (Ex. tamoxifen)
• bupropion (medicines used to treat depression)
• coumarins such as warfarin (medicines used to thin the blood)
• cyclosporine (medicines acting on the immune system)
• digoxin, β-acetyl digoxin (medicines used to treat heart conditions)
• vaccines Ex. BCG vaccine, anthrax vaccine (used to prevent infections)
• verapamil (medicines used to treat high blood pressure, angina or irregular heartbeat)
• clozapine (medicines used to treat psychotic disorders)

Overdosage:

PHOSMID 500MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms.

SYNOPSIS

MORE INFORMATION

• Keep PHOSMID 500MG INJECTION out of the sight and reach from children
• Store PHOSMID 500MG INJECTION refrigerated at 2°C to 8°C

FAQs ABOUT PHOSMID 500MG INJECTION

How PHOSMID 500MG INJECTION is given?

PHOSMID 500MG INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous injection or infusion. Your doctor will determine the correct dose and duration for you depending on your age, body weight and disease condition.

Does PHOSMID 500MG INJECTION cause hair loss?

Yes. PHOSMID 500MG INJECTION causes hair loss. Contact your doctor before receiving PHOSMID 500MG INJECTION.

Can I receive PHOSMID 500MG INJECTION during pregnancy?

No, PHOSMID 500MG INJECTION is not recommended for use by pregnant women. Contact your doctor before receiving PHOSMID 500MG INJECTION.

Does PHOSMID 500MG INJECTION cause mouth ulcers?

Yes. PHOSMID 500MG INJECTION causes mouth ulcers. Contact your doctor before receiving PHOSMID 500MG INJECTION.

Can I receive vaccines while using PHOSMID 500MG INJECTION?

No. Do not receive vaccines while using PHOSMID 500MG INJECTION. Contact your doctor before receiving PHOSMID 500MG INJECTION.

REFERENCES

1. Skidmore. Cyclophosphamide. Mosby’s 2021 Nursing Drug Reference. 34th edition. 2021. Page - 330-332.

2. Robert j. Kizior, Keith j. Hodgson. Cyclophosphamide. Saunder’s Nursing Drug Handbook 2021. 29th edition. 2021. Page -283-285.

3. Baxter Healthcare Corporation. U.S. Food & Drug Administration. [Revised on May 2013] [Accessed on 28th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf

4. Baxter Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised on June 2016] [Accessed on 28th May 2022] https://www.medicines.org.uk/emc/product/1815/smpc#PRODUCTINFO

5. AuroMedics Pharma LLC. Cyclophosphamide. [Revised on September 2021] [Accessed on 2th May 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c1eb470-0bba-457d-94e3-b9508f0d398a

6. Ingenus Pharmaceuticals, LLC. Cyclophosphamide. [Revised on November 2021] [Accessed on 2th May 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=783d7523-8505-4b3e-837c-cefbcec61da6

USEFUL DIAGNOSTIC TESTS

• Complete blood count
• Peripheral smear count
• Renal function test
• Liver function test
• Prothrombin time
• Triglycerides
• Urine albumin