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Melphalan parenteral 200mg

Updated 2 Feb 2023 | Alkylating agents


Parenteral formulations of melphalan.

Drugs List

  • melphalan 200mg powder and solvent for solution for infusion vials
  • PHELINUN 200mg powder and solvent for solution for infusion vials
  • Therapeutic Indications


    Breast cancer
    Conditioning prior to allogeneic haematopoietic stem cell transplant
    Leukaemia - acute lymphoblastic
    Leukaemia - acute myeloid
    Malignant lymphoma
    Myeloma - multiple
    Neuroblastoma in childhood
    Treatment of carcinoma of the ovary

    Alone or in combination in the treatment of:
    Multiple myeloma
    Malignant lymphoma (Hodgkin and non-Hodgkin lymphoma)
    Acute lymphoblastic and myeloblastic leukaemia
    Childhood neuroblastoma
    Ovarian cancer
    Mammary adenocarcinoma

    In combination as a reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.

    In combination as a conditioning regimen prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in haematological diseases in the paediatric patients as:
    Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases.
    RIC treatment in case of non-malignant haematological diseases.


    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.

    Doses may vary significantly if this agent is used as monotherapy or different combinations.

    When using this agent, specialist literature, national guidelines, cancer networks protocols and Trust chemotherapy protocols should be consulted.

    Melphalan should not be administered without haematopoietic stem cell rescue at doses above 140 mg/ metre squared of body surface area.

    Patients with Renal Impairment

    For high intravenous doses of melphalan (100 to 240mg per metre squared body surface area), the need for dose reduction depends on the degree of renal impairment, whether haematopoietic stem cells are re-infused and the therapeutic need.


    For intravenous use only.

    If a high dose of melphalan injection is administered with or without autologous bone marrow transplantation, administration via a central venous line is recommended.


    Child >12 years - if used as conditioning therapy prior to alloHSCT for AML

    Precautions and Warnings

    Children under 2 years
    History of progenitor cell transplantation
    Predisposition to thromboembolic disease
    Recent radiotherapy
    Restricted sodium intake
    Active liver disease
    Children under 2 years -if used as conditioning treatment prior to alloHSCT
    Epileptic disorder
    Renal impairment

    Administration of live vaccines is not recommended
    Reduce dose in patients with renal impairment
    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Consider use of anticoagulant prophylaxis if at risk of thromboembolism
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration during therapy
    Premedication with anti-infective recommended during treatment
    Treatment to be prescribed under the supervision of a specialist
    Contains alcohol
    Contains propylene glycol
    Consult local policy on the safe use of anti-cancer drugs
    Doses above 140mg per metre squared require haematopoietic stem cell rescue
    If accidental contact with eyes or mucous membranes - rinse with cool water
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Monitor blood counts regularly
    Monitor closely patient with pre-existing renal impairment
    Monitor hepatic function in patients with hepatic impairment
    Monitor patients for development of second primary malignancies
    Monitor renal function
    Consider hepatic veno-occlusive disease if hepatic impairment occurs
    Increased risk of venous thromboembolism
    Potentially leukaemogenic
    Potentially mutagenic
    Risk of myelodysplastic syndrome and secondary malignancies
    Interrupt therapy if leukocyte and platelet counts fall significantly
    Suspend treatment if thromboembolic events occur
    Male & female: May cause infertility
    Male & female: Contraception required during & for 6 months after treatment

    Patients with renal impairment should be closely observed as they may also have uraemic marrow suppression. Dosage reduction may be necessary for such patients. A clinically significant rise in blood urea may occur in patients with pre-existing renal impairment.

    Pregnancy and Lactation


    Melphalan is contraindicated during pregnancy.

    The manufacturer states that the use of melphalan should be avoided during pregnancy, particularly during the first trimester. Melphalan is mutagenic and structurally similar to known teratogenic compounds. It is possible that melphalan could cause congenital defects in the offspring of patients treated with the drug. The potential hazard to the foetus must be balanced against the expected benefit to the mother.

    The effect of concurrent therapies must also be considered.


    Melphalan is contraindicated during breastfeeding.

    The manufacturer recommends that melphalan is contraindicated during breastfeeding. Due to the low molecular weight of melphalan, excretion into the breast milk is likely. Therefore there is the potential for severe toxicity in the nursing infant.

    The effect of concurrent therapies must also be considered.

    Side Effects

    Abdominal distension
    Abnormal liver function tests
    Acute kidney injury
    Acute myeloid leukaemia
    Acute respiratory distress syndrome
    Allergic reaction
    Anaphylactic shock
    Bone marrow depression
    Cardiac arrest
    Cardiac failure
    Creatine phosphokinase increased
    Deep vein thrombosis (DVT)
    Feeling hot
    Gastro-intestinal haemorrhage
    Graft versus host disease
    Haemolytic anaemia
    Haemophagocytic lymphohistiocytosis
    Haemorrhagic cystitis
    Interstitial lung disease
    Intracranial bleeding
    Maculopapular rash
    Mucosal inflammation
    Multiorgan failure
    Myelodysplastic syndrome
    Pulmonary fibrosis
    Pulmonary haemorrhage
    Pulmonary hypertension
    Renal failure
    Respiratory failure
    Second primary malignancies
    Septic shock
    Stevens-Johnson syndrome
    Thrombotic microangiopathy
    Toxic epidermal necrolysis
    Veno-occlusive disease


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2022

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Phelinun 200mg powder and solvent for concentrate for solution for infusion. Adienne S.r.l. S.U. Revised January 2021.

    The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

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