Multiple Myeloma Treatments
Find Multiple Myeloma Treatments
Generic Name
Melphalan
Brand Names
Evomela, Hepzato, IVRA
FDA approval date: January 10, 2013
Classification: Alkylating Drug
Form: Injection, Kit
What is Evomela (Melphalan)?
Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials
Summary: This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A b...
A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma
Summary: This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neur...
Phase 1 of Exposure Targeted Melphalan Dosing
Summary: This phase I trial studies the best dose and side effects of mephalan in treating patients with multiple myeloma who are undergoing stem cell transplant. Chemotherapy drugs, such as mephalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial uses a new method of dosing that is based...
Related Latest Advances
Brand Information
EVOMELA (Melphalan)
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY
- Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters.
- Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions.
- Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans.
1DOSAGE FORMS AND STRENGTHS
For injection: 50 mg, white to off-white lyophilized powder in single-dose vial for reconstitution (after reconstitution the solution is clear and colorless to light yellow). Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.
2CONTRAINDICATIONS
History of serious allergic reaction to melphalan.
3DRUG INTERACTIONS
No formal drug interaction studies have been conducted. The development of severe renal impairment has been reported in patients treated with a single dose of intravenous melphalan 140-250 mg/m
4OVERDOSAGE
Overdoses resulting in death have been reported with melphalan. Overdoses, including doses up to 290 mg/m
The principal toxic effect is bone marrow suppression leading to leucopenia, thrombocytopenia and anemia. Hematologic parameters should be closely followed for 3 to 6 weeks. An uncontrolled study suggests that administration of autologous bone marrow or hematopoietic growth factors (i.e., sargramostim, filgrastim) may shorten the period of pancytopenia. General supportive measures together with appropriate blood transfusions and antibiotics should be instituted as deemed necessary by the physician. This drug is not removed from plasma to any significant degree by hemodialysis or hemoperfusion. A pediatric patient survived a 254 mg/m
5DESCRIPTION
Evomela contains melphalan hydrochloride, an alkylating drug, as the active ingredient. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. Its molecular formula is C
Melphalan hydrochloride is a white to off-white powder, with a melting range of 199°C − 201°C. It is practically insoluble in water, but freely soluble in 1N HCl and methanol.
Evomela (melphalan) for injection is supplied as a sterile white to off-white lyophilized powder in a single-dose vial for intravenous use. Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride and 2700 mg Betadex Sulfobutyl Ether Sodium, NF. Sodium hydroxide and if necessary, hydrochloric acid are added as a pH adjuster.
6REFERENCES
- OSHA Hazardous Drugs. OSHA. [Accessed on 9 December 2014, from
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Evomela is supplied in a single carton containing one (1) vial. Each 50 mg vial contains a white to off- white lyophilized powder in single-dose vial for reconstitution (after reconstitution the solution is clear and coloress to light yellow). Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.
NDC 72893-001-01: Individual carton of Evomela single-dose vial containing 50 mg melphalan free base.
Storage and Handling
Store Evomela at room temperature 25°C (77°F). Temperature excursions are permitted between 15- 30°C (59-86°F). [see USP Controlled Room Temperature]
Evomela is light sensitive. Retain in original carton until use.
Melphalan is a hazardous drug. Follow applicable special handling and disposal procedures.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients or their caregivers of the following:
Low Blood Cell Counts
- To report any signs or symptoms of thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia. Inform patients of the need for routine blood counts
Mucositis
- Inform patients of the signs and symptoms of mucositis. Instruct patients on ways to reduce the risk of its development, and on ways to maintain nutrition and control discomfort if it occurs
Nausea, Vomiting and Diarrhea
- To report symptoms of nausea, vomiting and diarrhea, so that appropriate antiemetic and/or antidiarrheal medications can be administered
Allergic Reactions
- To immediately report symptoms of hypersensitivity reactions including changes involving the skin, breathing or heart rate, so that antihistamine or corticosteroid therapy can be administered
Secondary cancers
- To understand the potential long-term risks related to secondary malignancy
Embryo-Fetal Toxicity
- Advise pregnant women of the potential risk to a fetus
- Advise females of reproductive potential to use effective contraception during treatment with Evomela and for 6 months after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking Evomela
- Inform both females and males of reproductive potential about the risk for infertility
- Advise males with female partners of reproductive potential to use effective contraception during treatment with Evomela and for 3 months after the last dose
Lactation
- Advise women not to breastfeed during treatment with Evomela and for one week after the last dose
Manufacturer by:
Manufactured for:
9PATIENT INFORMATION
EVOMELA (ev-o-meh-lah)
(melphalan) for injection, for intravenous use
(melphalan) for injection, for intravenous use
What is Evomela?
Evomela is a prescription medicine used in people with a type of cancer called multiple myeloma before receiving a stem cell transplant (conditioning treatment).
It is not known if Evomela is safe and effective in children.
Before you receive Evomela, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection
- have had chemotherapy treatment
- have nausea, vomiting, or diarrhea
- have liver or kidney problems
- are pregnant or plan to become pregnant. Evomela can harm your unborn baby.
Females who can become pregnant:
o You should not become pregnant during treatment with Evomela.
Males with female partners who can become pregnant:
o You should use effective birth control (contraception) during treatment and for 3 months after your last dose of Evomela.
- are breastfeeding or plan to breastfeed. It is not known if Evomela passes into your breast milk. You should not breastfeed during treatment with Evomela.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Evomela?
- Evomela is given to you into your vein through an intravenous (IV) line over 30 minutes.
- Your healthcare provider will do blood tests before and during your treatment with Evomela.
- Your healthcare provider will prescribe medicines to help prevent nausea.
What are the possible side effects of Evomela?
Evomela may cause serious side effects, including:
Evomela may cause serious side effects, including:
- Low blood cell counts are common with Evomela and can be serious. Your healthcare provider will do blood tests as needed to check your blood counts during your treatment with Evomela.
ᴼ
- Redness and sores of the lining of the mouth, lips, throat, stomach, and genitals (mucositis). Mucositis is common during treatment with Evomela, and can sometimes be severe. Mucositis may cause discomfort or pain.
Your healthcare provider will tell you about ways to maintain nutrition and help control the discomfort from mucositis, and may prescribe medicines if needed. - Nausea, vomiting, and diarrhea are common with Evomela and can sometimes be serious. Tell your healthcare provider if you get nausea, vomiting, or diarrhea. Your healthcare provider may prescribe medicines to help prevent or treat these side effects.
- Liver problems. Your healthcare provider will check you for liver problems during treatment with Evomela. Tell your healthcare provider right away if you get any of the following signs or symptoms:
ᴼ yellowing of your skin or the whites of your eyes
ᴼ pain on the right side of your stomach-area (abdomen)
ᴼ severe nausea or vomiting
ᴼ dark urine (tea colored)
- Serious Allergic reactions. Tell your healthcare provider right away if you get any of the following signs or symptoms:
ᴼ skin reactions, including welts, rash, itching, and redness
ᴼ fast heartbeat
ᴼ shortness of breath or trouble breathing
ᴼ feel lightheaded or dizzy
ᴼ blurry vision
ᴼ swelling of your face, tongue, or thro
ᴼ chest tightness
ᴼ wheezingt
Your healthcare provider may need to discontinue treatment with Evomela if you have a serious allergic reaction.
- Secondary cancers. New cancers have happened in people who have been treated with Evomela.
- Infertility. Evomela may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you. In females, your menstrual periods may stop due to treatment with Evomela.
The most common side effects of Evomela include
These are not all the possible side effects of Evomela.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Evomela.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Evomela that is written for health professionals.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Evomela that is written for health professionals.
What are the ingredients in Evomela?
Active ingredient: melphalan hydrochloride
Inactive ingredient: Betadex Sulfobutyl Ether Sodium. Sodium hydroxide and if necessary, hydrochloride acid is added as a pH adjuster.
Active ingredient: melphalan hydrochloride
Inactive ingredient: Betadex Sulfobutyl Ether Sodium. Sodium hydroxide and if necessary, hydrochloride acid is added as a pH adjuster.
Manufacturer by:
Manufactured for:
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Evomela Carton Label
NDC 72893-001-01
Evomela
50 mg per vial*
For Intravenous Infusion Only
Single-Use Vial
Discard Unused Portion
Sterile
*Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.
Acrotech Biopharma Inc.
Evomela Vial Label
NDC 72893-001-01
Evomela
50 mg per vial*
For Intravenous Infusion Only
Single-Use Vial Discard Unused Portion
Sterile
*Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.
Rx only