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Melphalan
Overview
What is EVOMELA?
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 CHClNO • HCl and the molecular weight is 341.67. The structural formula is:
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 1 N 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.
What does EVOMELA look like?
What are the available doses of EVOMELA?
For Injection: 50 mg per vial, lyophilized powder in a single-dose vial for reconstitution. ()
What should I talk to my health care provider before I take EVOMELA?
How should I use EVOMELA?
Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
The recommended dose of Evomela for conditioning treatment is 100 mg/m/day administered over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0). For patients who weigh more than 130% of their ideal body weight, body surface area should be calculated based on adjusted ideal body weight.
Administer prophylactic antiemetics .
What interacts with EVOMELA?
Sorry No Records found
What are the warnings of EVOMELA?
Sorry No Records found
What are the precautions of EVOMELA?
Sorry No Records found
What are the side effects of EVOMELA?
Sorry No records found
What should I look out for while using EVOMELA?
History of serious allergic reaction to melphalan.
What might happen if I take too much EVOMELA?
Overdoses resulting in death have been reported with melphalan. Overdoses, including doses up to 290 mg/m, have produced the following symptoms: severe nausea and vomiting, decreased consciousness, convulsions, muscular paralysis, and cholinomimetic effects. Severe mucositis, stomatitis, colitis, diarrhea, and hemorrhage of the gastrointestinal tract occur at high doses (>100 mg/m). Elevations in liver enzymes and veno-occlusive disease occur infrequently. Significant hyponatremia, caused by an associated inappropriate secretion of ADH syndrome, has been observed. Nephrotoxicity and adult respiratory distress syndrome have been reported rarely.
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 overdose treated with standard supportive care.
How should I store and handle EVOMELA?
Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYProchlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13 Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP.The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5105-01 bottles of 100 tablets The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with on one side and on the other side. They are available as follows: NDC 0378-5110-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.*Levophed is a registered trademark of Abbott Laboratories. **Neo-Synephrine is a registered trademark of Abbott Laboratories. ***Dilantin is a registered trademark of Parke-Davis. †Amipaque is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl is a registered trademark of Parke-Davis. Mylan Pharmaceuticals Inc. Revised: 11/2016 PCPZ:R13
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.
Non-Clinical Toxicology
History of serious allergic reaction to melphalan.Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.
Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.
Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).
Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QTprolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.
For patients receiving Evomela as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.
For patients receiving Evomela as palliative treatment, if the bone marrow has been compromised by prior irradiation, prior chemotherapy or is recovering from chemotherapy, the risk of severe myelosuppression with Evomela is increased. Perform periodic complete blood counts during the course of treatment with Evomela. Provide supportive care for infections, bleeding, and symptomatic anemia
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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