Cyclocel 1000Mg Injection 1?s Allschoolabs -

Description

INTRODUCTION
CYCLOCEL 1000MG 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.
CYCLOCEL 1000MG 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. CYCLOCEL 1000MG 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 CYCLOCEL 1000MG 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.
CYCLOCEL 1000MG INJECTION is not recommended for use by pregnant women. CYCLOCEL 1000MG INJECTION is generally not recommended for use in breastfeeding women as it may pass through the breast milk. CYCLOCEL 1000MG INJECTION should be used with caution in children and the elderly. The most common side effects of receiving CYCLOCEL 1000MG INJECTION are nausea, vomiting, weight loss, alopecia, hematuria and leukopenia. Contact your doctor if any of your symptoms get worse or persist.
USES OF CYCLOCEL 1000MG 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 CYCLOCEL 1000MG INJECTION WORKS
CYCLOCEL 1000MG INJECTION works by interfering with the malignant cell growth by cross-linking of cancer cells? DNA. CYCLOCEL 1000MG 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
CYCLOCEL 1000MG 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 CYCLOCEL 1000MG INJECTION

COMMON

Nausea, vomiting, weight loss

Alopecia (loss of hair)

Hematuria

Leukopenia

UNCOMMON

Diarrhea

Darkening of skin/fingernails

Stomatitis, anorexia

Headache

Diaphoresis

SIADH, gonadal suppression

Hyperuricemia

Impaired wound healing

Amenorrhea, premature menopause, sterility

RARE

Pain and redness at the injection site
Stop receiving CYCLOCEL 1000MG INJECTION and contact your doctor immediately if you experience any of the following side effects:
Allergic reactions such as anaphylaxis, swelling of the face, lips, ankles/legs causing shortness of breath

Palpitations

Weight gain, dizziness or loss of consciousness

Signs of infection include fever, sore throat, cold and cough

Signs of bleeding from gums, bruising and petechiae due to a decrease in platelet count

Haematuria (blood in urine)

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

PREGNANCY
CYCLOCEL 1000MG INJECTION is generally not recommended for use in pregnant women. Consult your doctor before receiving CYCLOCEL 1000MG INJECTION.
BREASTFEEDING
CYCLOCEL 1000MG INJECTION is generally not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before receiving CYCLOCEL 1000MG INJECTION.
DRIVING AND USING MACHINES
Do not drive or operate any machinery if you feel dizziness, blurred vision and visual impairment after receiving CYCLOCEL 1000MG INJECTION.
ALCOHOL
Avoid consumption of alcohol while receiving CYCLOCEL 1000MG INJECTION as it leads to unwanted effects.
KIDNEY
CYCLOCEL 1000MG INJECTION should be used with caution in patients with kidney diseases such as nephrotoxicity, including renal tubular necrosis. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
LIVER
CYCLOCEL 1000MG INJECTION should be used with caution in patients with liver disease such as veno-occlusive liver disease. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
ALLERGY
Do not receive CYCLOCEL 1000MG INJECTION if you are allergic to Cyclophosphamide or any of its metabolites or other ingredients of this medicine.
LUNGS
[GBNEYWORD] should be used with caution in patients with lung diseases such as pneumonia, pulmonary fibrosis, pulmonary venous-occlusive disease, respiratory failure and pneumonitis. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
HEART DISEASE
CYCLOCEL 1000MG INJECTION should be used with caution in patients with heart disease such as myocarditis, myopericarditis and pericardial effusion including cardiac tamponade, congestive heart failure, ventricular arrhythmias (including atrial fibrillation, flutter and severe QT prolongation with ventricular tachyarrhythmia). Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
OTHERS
CYCLOCEL 1000MG INJECTION is not recommended for use if you have:
Acute infections

Bone-marrow aplasia

Urinary tract infection like cystitis

Acute urothelial toxicity from cytotoxic chemotherapy and radiation

Urinary outflow obstruction
Before receiving CYCLOCEL 1000MG INJECTION, inform your doctor if you have:
Allergic or anaphylactic reactions to other alkylating agents

Bone marrow suppression or failure includes (leukopenia, neutropenia, thrombocytopenia and anaemia)

Neutropenic fever

Serious infections include pneumonia, 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

Active urinary tract infections

Secondary malignancies (urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, sarcomas and bladder cancer)

Poor wound healing

Hyponatremia

Syndrome of inappropriate secretion of antidiuretic hormone
Use in pediatrics:
CYCLOCEL 1000MG INJECTION should be used with caution in children. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
Use in geriatrics:
CYCLOCEL 1000MG INJECTION should be used with caution in elderly patients aged 65 years or above. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving CYCLOCEL 1000MG 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, ?-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:
CYCLOCEL 1000MG 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

Drug :?? Cyclophosphamide

Pharmacological Category :?? Alkylating agents

Therapeutic Indication :?? Cancers

Dosage Forms :?? Tablet, Injection, Infusion

MORE INFORMATION

Keep CYCLOCEL 1000MG INJECTION out of the sight and reach from children

Store CYCLOCEL 1000MG INJECTION refrigerated at 2?C to 8?C

FAQs ABOUT CYCLOCEL 1000MG INJECTION
How CYCLOCEL 1000MG INJECTION is given?
CYCLOCEL 1000MG 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 CYCLOCEL 1000MG INJECTION cause hair loss?
Yes. CYCLOCEL 1000MG INJECTION causes hair loss. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
Can I receive CYCLOCEL 1000MG INJECTION during pregnancy?
No, CYCLOCEL 1000MG INJECTION is not recommended for use by pregnant women. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
Does CYCLOCEL 1000MG INJECTION cause mouth ulcers?
Yes. CYCLOCEL 1000MG INJECTION causes mouth ulcers. Contact your doctor before receiving CYCLOCEL 1000MG INJECTION.
Can I receive vaccines while using CYCLOCEL 1000MG INJECTION?
No. Do not receive vaccines while using CYCLOCEL 1000MG INJECTION. Contact your doctor before receiving CYCLOCEL 1000MG 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
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