Doxorubicin

Registered South African indications:

• Solid tumours
• Acute leukaemias
• Metastatic breast cancer
• Ovarian cancer
• Multiple myeloma
• AIDS-related Kaposi's sarcoma

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Kaposi's Sarcoma that may be treated effectively with local therapy or systemic alfa-interferon
• Persistent myelosuppression
• Severe myocardial insufficiency
• Recent myocardial infarction
• Severe arrhythmias
• Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones

Cautions

• End-stage renal impairment
• Mild to moderate hepatic impairment ₈
• Elderly
• Diabetes mellitus
• Acute toxicities of prior cytotoxic treatment
• Obese patients
• Cardiovascular disease
• High cumulative doses
• Female patients
• Concomitant radiotherapy to the mediastinal or pericardial area
• Previous therapy with other anthracyclines or anthracenediones

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

• Solid tumours
• Acute leukaemias
• Metastatic breast cancer
• Ovarian cancer
• Multiple myeloma
• AIDS-related Kaposi's sarcoma

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Consult specialist for dosages and regimens

Not established for use in children 

Pregnancy

• Caution; positive evidence of risk
• Doxorubicin should not be given during pregnancy. In general, cytostatics should only be administered during pregnancy on strict indication, and the benefit to the mother weighed against possible hazards to the foetus. In animal studies, doxorubicin has shown embryo-, feto- and teratogenic effects
•  Women should not become pregnant during and up to 6 months after treatment. Men treated with doxorubicin are advised not to father a child during and up to 6 months after treatment. Men and women should use effective contraception during and up to 6 months after treatment

Breastfeeding

• Contraindicated
• Doxorubicin has been reported to be excreted in human breast milk. A risk to the suckling child cannot be excluded. Since the use of doxorubicin during breastfeeding is contraindicated, breastfeeding should be discontinued during treatment with doxorubicin

Renal Impairment

• GFR ≥10ml/min: No dose adjustment recommended
• GFR <10ml/min: Caution; dose adjustment recommended
  Administer 75% of the calculated dose

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
• Severe: Contraindicated

Serum bilirubin (mg/100ml)	Dose
1.2-3.0	Administer 50% dose
3.1-5.0	Administer 25% dose
>5.0	Contraindicated

Elderly

• Dose adjustment should be considered and calculated based on the patients: Body Surface Area (BSA), renal function (eGFR) and neutrophil counts (FBC)

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Paresthesia
• Somnolence
• Peripheral neuropathy
• Anxiety
• Depression
• Insomnia
• Headache
• Dizziness
• Neuropathy
• Asthenia
• Fatigue
• Weakness
• Hypertonia
• Confusion
• Paresthesia

Cardiovascular Disorders

• Ventricular arrhythmia
• Vasodilatation
• Venous thromboembolism

Respiratory Disorders

• Epistaxis
• Upper respiratory tract infection
• Pharyngitis
• Dyspnoea
• Increased cough

Gastrointestinal Disorders

• Nausea and vomiting
• Stomatitis
• Abdominal pain
• Constipation
• Diarrhoea
• Dyspepsia
• Mouth ulceration
• Oral pain
• Esophagitis
• Gastritis
• Dry mouth
• Flatulence
• Gingivitis
• Taste perversion
• Glossitis

Genitourinary Disorders

• Breast pain
• Vaginitis
• Urinary tract infection
• Dysuria

Endocrine and Metabolic Disorders

• Anorexia
• Dehydration
• Cachexia

Musculoskeletal Disorders

• Leg cramps
• Bone pain
• Musculoskeletal pain
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Palmar-plantar erythrodysesthesia
• Alopecia
• Rash
• Dry skin
• Skin discolouration
• Abnormal pigmentation 
• Erythema
• Bullous eruption
• Dermatitis
• Nail disorder
• Scaly skin
• Pruritus
• Exfoliative dermatitis
• Sweating
• Acne
• Skin ulcer
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Leukopaenia
• Anaemia
• Neutropaenia
• Thrombocytopenia
• Hypochromic anaemia
• Folliculitis
• Fungal infection
• Cold sores (non-herpetic)
• Oral moniliasis
• Herpes simplex
• Allergic reaction

Sensory Disorders

• Lacrimation
• Blurred vision
• Conjunctivitis
• Retinitis

Others

• Fever
• Pain
• Oedema
• Mucous membrane disorder
• Chills
• Chest pain
• Infusion-associated acute reactions

• Live or live-attenuated vaccines
• Cardiotoxic agents
• Agents that suppress cardiac contractility
• Cyclophosphamide 
• 6-Mercaptopurine 
• Myelotoxic agents
• Alkaline solutions
• Heparin
• CYP3A4 inhibitors
• CYP2D6 inhibitors
• P-gp inhibitors and inducers
• CYP3A4 inducers
• Cyclosporine 
• Cytotoxic agents
• Paclitaxel 
• Sorafenib 

• Cardiac function
• Full blood count

Specific cases may require

• Hepatic function

Doxorubicin is a cytotoxic anthracycline antibiotic; it forms complexes with DNA by intercalation of the anthracycline between adjacent base pairs of the DNA double helix, thus preventing their unwinding for replication.

Injection (per ml) 2mg

• Caelyx (Janssen) originator
• Doxolip (Ranbaxy)
• Doxopeg (Key Oncologics)
• Doxorubicin Accord (Accord)
• Doxorubicin "Ebewe" (Key Oncologics)
• Doxorubicin-Hexal (Sandoz)
• Doxorubicin-Rtu (Pharmachemie)
• Rubexet (Accord)
• Sopilcin 20mg/10ml (Dr Reddy's Laboratories)

Injection (per vial) 10mg

• Cipla doxorubicin (Cipla)
• Doxorubicin Pch (Pharmachemie)
• Doxorubicin -Sol Pch (Teva)
• Doxorubicin Accord (Accord) 

Injection (per vial) 50mg

• Cipla doxorubicin (Cipla)
• Doxorubicin hcl faulfing powder vial (Pharmaplan)
• Doxorubicin Pch (Pharmachemie)
• Doxorubicin Accord (Accord) 

Injection (5ml) 10mg

• Doxorubicin 10mg/5ml Fresenius (Fresenius Kabi SA)
• Doxorubicin "Ebewe" (Key Oncologics)
• Doxorubicin-Hexal (Sandoz)
• Rubexet rtu concentrate solution for infusion (Accord)

Injection (25ml) 50mg

• Doxorubicin 50mg/25ml Fresenius (Fresenius Kabi SA)
• Doxorubicin "Ebewe" (Key Oncologics)
• Doxorubicin-Hexal (Sandoz)
• Doxorubicin-Sol PCH (Teva Pharmaceuticals)
• Rubexet rtu concentrate solution for infusion (Accord)

Injection (100ml) 200mg

• Doxorubicin Rtu (Pharmachemie)
• Doxorubicin-Sol PCH (Teva Pharmaceuticals)
• Rubexet rtu concentrate solution for infusion (Accord)