Alkeran

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Alkeran uses


1 INDICATIONS AND USAGE

Alkeran is an alkylating drug indicated for:

1.1 Multiple Myeloma-Conditioning Treatment

Alkeran is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.

1.2 Multiple Myeloma-Palliative Treatment

Alkeran is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Conditioning Treatment

The recommended dose of Alkeran for conditioning treatment is 100 mg/m2/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 .

2.2 Recommended Dosage for Palliative Treatment

The recommended dose of Alkeran for palliative treatment is 16 mg/m2 administered as a single intravenous infusion over 15-20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4‑week intervals.

Administer prophylactic anti-emetics [see Warnings and Precautions .

2.3 Dose Modification for Renal Impairment

For Conditioning Treatment: No dose adjustment is necessary.

For Palliative Treatment: Dosage reduction of up to 50% should be considered in patients with renal impairment (BUN ≥30 mg/dL) .

2.4 Preparation and Administration

Alkeran is a cytotoxic drug. Follow applicable special handling and disposal procedures1.

Alkeran is light sensitive. Retain in original carton until use.

Do not mix Alkeran with other Alkeran hydrochloride for injection drug products.

Reconstitution and Infusion Instructions:

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3 DOSAGE 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 Alkeran free base equivalent to 56 mg Alkeran hydrochloride.

For Injection: 50 mg per vial, lyophilized powder in a single-dose vial for reconstitution. (3)

4 CONTRAINDICATIONS

History of serious allergic reaction to Alkeran.

5 WARNINGS AND PRECAUTIONS

5.1 Bone Marrow Suppression

For patients receiving Alkeran 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 Alkeran 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 Alkeran is increased. Perform periodic complete blood counts during the course of treatment with Alkeran. Provide supportive care for infections, bleeding, and symptomatic anemia .

5.2 Gastrointestinal Toxicity

For patients receiving Alkeran as part of a conditioning regimen, nausea, vomiting, mucositis, and diarrhea may occur in over 50% of patients. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. The frequency of grade 3/4 mucositis in clinical studies was 13%. Provide nutritional support and analgesics for patients with severe mucositis. .

For patients receiving Alkeran as palliative treatment, nausea and vomiting, diarrhea, and oral ulceration may occur. Use prophylactic antiemetics. Provide supportive care for nausea, vomiting, diarrhea and mucositis.

5.3 Hepatotoxicity

Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with Alkeran. Hepatic veno-occlusive disease has also been reported. Monitor liver chemistries.

5.4 Hypersensitivity

Acute hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous formulation of Alkeran. Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. Discontinue treatment with Alkeran for serious hypersensitivity reactions.

5.5 Secondary Malignancies

Alkeran has been shown to cause chromatid or chromosome damage in humans. Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens. The potential benefit of Alkeran therapy must be considered against the possible risk of the induction of a secondary malignancy.

5.6 Embryo-Fetal Toxicity

Based on its mechanism of action, Alkeran can cause fetal harm when administered to a pregnant woman. Alkeran is genotoxic, targets actively dividing cells, and was embryolethal and teratogenic in rats. Advise females of reproductive potential to avoid pregnancy during and after treatment with Alkeran. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus .

5.7 Infertility

Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported.

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6 ADVERSE REACTIONS

Most common adverse reactions observed in at least 50% of patients treated with Alkeran are neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting.

To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

The following serious adverse reactions are described in more detail in other sections of the prescribing information.

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Alkeran may not reflect the rates observed in practice.

The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with Alkeran were neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting.

Myeloablative Conditioning in Multiple Myeloma Patients Undergoing ASCT

The safety of Alkeran was evaluated in 61 patients with multiple myeloma in a single arm clinical trial in which patients were administered Alkeran at a dosage of 100 mg/m2/day administered over ~30 minutes (range: 24-48 minutes) by intravenous (IV) infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplant (ASCT, Day 0).

Table 1 summarizes the adverse reactions from the single-arm trial in patients with multiple myeloma. Severe myelosuppression is expected and these adverse reactions are not listed below.

Adverse Reactions Number (%) of Patients

(N=61)

All Grades Grade 3or 4

All Adverse Reactions


61


61


Diarrhea


57 (93%)


2 (3%)


Nausea


55 (90%)


1 (2%)


Fatigue


47 (77%)


1 (2%)


Hypokalemia


45 (74%)


17 (28%)


Vomiting


39 (64%)


0 (0%)


Hypophosphatemia


30 (49%)


29 (48%)


Decreased Appetite


30 (49%)


0 (0%)


Pyrexia


29 (48%)


2 (3%)


Constipation


29 (48%)


0 (0%)


Febrile Neutropenia


25 (41%)


17 (28%)


Mucosal Inflammation


23 (38%)


6 (10%)


Dizziness


23 (38%)


0 (0%)


Edema Peripheral


20 (33%)


0 (0%)


Stomatitis


17 (28%)


3 (5%)


Abdominal Pain


17 (28%)


0 (0%)


Dysgeusia


17 (28%)


0 (0%)


Dyspepsia


16 (26%)


0 (0%)


Serious Adverse Reactions

Twelve (20%) patients experienced a treatment emergent serious adverse reaction while on study. The most common serious adverse reactions (>1 patient, 1.6%) were pyrexia, hematochezia, febrile neutropenia, and renal failure. Treatment-related serious adverse reactions reported in >1 patient were pyrexia (n=2, 3%), febrile neutropenia (n=2, 3%), and hematochezia (n=2, 3%).

Palliative Treatment of Patients with Multiple Myeloma

The safety of Alkeran was evaluated in 295 patients with multiple myeloma in the randomized clinical trial. One hundred and ninety-five patients were administered IV Alkeran at a dosage of 16 mg/m2 q 2 weeks x 4 (over 6 weeks) followed by the same dose every 4 weeks. One hundred patients were administered oral Alkeran at a dosage of 0.15 mg/kg/day x 7 followed by 0.05 mg/kg/day when WBC counts began to rise.

Severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common in the IV Alkeran arm (28%) than in the oral Alkeran arm (11%).

An association was noted between poor renal function and myelosuppression; consequently, an amendment to the protocol required a 50% reduction in IV Alkeran dose if the BUN was ≥30 mg/dL. The rate of severe leukopenia in the IV arm in the patients with BUN over 30 mg/dL decreased from 50% (8/16) before protocol amendment to 11% (3/28) after the amendment.

Before the dosing amendment, there was a 10% (8/77) incidence of drug-related death in the IV arm. After the dosing amendment, this incidence was 3% (3/108). This compares to an overall 1% (1/100) incidence of drug-related death in the oral Alkeran arm.

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7 DRUG 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 Alkeran 140-250 mg/m2 followed by standard oral doses of cyclosporine. Intravenous Alkeran may also reduce the threshold for BCNU lung toxicity. When nalidixic acid and IV Alkeran are given simultaneously, the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric patients.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on its mechanism of action, Alkeran can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality. Alkeran is a genotoxic drug and can cause chromatid or chromosome damage in humans . In animal studies, Alkeran was embryolethal and teratogenic in rats at doses below the recommended clinical doses . Advise a pregnant woman of the potential risk to a fetus..

The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Data

Animal Data

Adequate animal studies have not been conducted with intravenous Alkeran. Alkeran was embryolethal and teratogenic in rats following oral administration of 6 to 18 mg/m2/day for 10 days (0.06 to 0.18 times the highest recommended clinical dose of 100 mg/m2/day) and intraperitoneal administration of 18 mg/m2 (0.18 times the highest recommended clinical dose). Malformations resulting from Alkeran administration included alterations of the brain (underdevelopment, deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of the mandible and tail, and hepatocele (exomphaly).

8.2 Lactation

Risk Summary

It is not known whether Alkeran is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Alkeran, breastfeeding is not recommended during treatment with Alkeran.

8.3 Females and Males of Reproductive Potential

Contraception

Females

Alkeran administration can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy, which may include the use of effective contraception methods, during and after treatment with Alkeran.

Males

Alkeran administration may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Advise males with female sexual partners of reproductive potential to use effective contraception during and after treatment with Alkeran [see Nonclinical Toxicology ].

Infertility

Females

Alkeran causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients.

Males

Reversible and irreversible testicular suppression has been reported in male patients after administration of Alkeran.

8.4 Pediatric Use

Pediatric patients were not included in clinical trials. Safety and effectiveness have not been established in pediatric patients.

8.5 Geriatric Use

Of the total number of subjects in the single-arm pivotal study of Alkeran, 30% were 65 and over, but no patients were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. A greater incidence of engraftment syndrome was observed in older patients; 7% of patients younger than 65 years old versus 28% (5 of 18) of patients 65 years old and over.

8.6 Patients with Renal Impairment

For Conditioning Treatment, renal impairment is not a criterion for dose reduction or exclusion from Alkeran therapy.

For Palliative Treatment, consider dose reduction for patients with renal impairment receiving Alkeran. Bone marrow suppression has been observed in patients with BUN levels ≥30 mg/dL. A 50% reduction in the IV Alkeran dose decreased the incidence of severe bone marrow suppression in the latter portion of this study .

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10 OVERDOSAGE

Overdoses resulting in death have been reported with Alkeran. Overdoses, including doses up to 290 mg/m2, 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/m2). 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/m2 overdose treated with standard supportive care.

11 DESCRIPTION

Alkeran contains Alkeran hydrochloride, an alkylating drug, as the active ingredient. The chemical name of Alkeran hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. Its molecular formula is C13H18Cl2N2O2 - HCl and the molecular weight is 341.67. The structural formula is:

Alkeran 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.

Alkeran (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 Alkeran free base equivalent to 56 mg Alkeran hydrochloride and 2700 mg Betadex Sulfobutyl Ether Sodium, NF.

Alkeran structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Alkeran 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 N7 position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.

12.2 Pharmacodynamics

Cardiac Electrophysiology

Pharmacokinetic-pharmacodynamic analysis showed that Alkeran administration increased heart rate-corrected QT interval. The mean change from baseline for QTcF at the mean Cmax of 4701 ng/mL was 8.0 msec. Patients treated with 200 mg/m2 Alkeran showed an increase of heart rate.

12.3 Pharmacokinetics

Following injection, drug plasma concentrations declined rapidly in a biexponential manner with distribution phase and terminal elimination phase half-lives of approximately 10 and 75 minutes, respectively. Estimates of average total body clearance (CL) varied among studies, but typical values of approximately 7 to 9 mL/min/kg (250 to 325 mL/min/m2) were observed. One study reported that on repeat dosing of 0.5 mg/kg every 6 weeks, the clearance of Alkeran decreased from 8.1 mL/min/kg after the first course, to 5.5 mL/min/kg after the third course, but did not decrease appreciably after the third course. Mean (±SD) peak Alkeran plasma concentrations in myeloma patients given IV Alkeran at doses of 10 or 20 mg/m2 were 1.2 ± 0.4 and 2.8 ± 1.9 mcg/mL, respectively.

Distribution

The steady-state volume of distribution of Alkeran is 0.5 L/kg. Alkeran penetrates into cerebrospinal fluid (CSF). Average Alkeran binding to plasma proteins ranges from approximately 50% to 90%. Serum albumin is the major binding protein, accounting for approximately 40% to 60% of the plasma protein binding, while α1-acid glycoprotein accounts for about 20% of the plasma protein binding. Approximately 30% of Alkeran is (covalently) irreversibly bound to plasma proteins.

Elimination

Metabolism

Alkeran is eliminated from plasma primarily by chemical hydrolysis to inactive monohydroxymelphalan and dihydroxymelphalan.

Excretion

The contribution of renal excretion to Alkeran clearance appears to be low (mean values of amount of Alkeran excreted in urine range from 5.8-21.3%).

Specific Populations

Patient Body Weight

A typical patient with an ideal body weight (IBW) of 45 kg has a 28% decrease in clearance relative to a patient with IBW of 70 kg, while a patient with an IBW of 100 kg has a 31% increase in clearance as compared to a patient with an IBW of 70 kg.

Renal Impairment

A decrease in estimated creatinine CL from 100 mL/min to 30 mL/min results in 28.2% reduction in CL for a typical person with an IBW of 70 kg.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate and well-controlled carcinogenicity studies have not been conducted in animals. However, intraperitoneal (IP) administration of Alkeran in rats (5.4 to 10.8 mg/m2) and in mice (2.25 to 4.5 mg/m2) 3 times per week for 6 months followed by 12 months post-dose observation produced peritoneal sarcomas and lung tumors, respectively.

Intramuscular administration of Alkeran at 6 and 60 mg/m2 produced structural aberrations of the chromatid and chromosomes in bone marrow cells of Wistar rats.

14. CLINICAL STUDIES

14.1 Myeloablative Conditioning in Patients with Multiple Myeloma Undergoing ASCT

An open-label, single-arm, non-randomized trial of Alkeran was conducted at 5 US centers. The 61 patients enrolled had symptomatic multiple myeloma, and had at least 2 × 106 CD34+ cells/kg cryopreserved stem cells available. The median age was 62 years ; 57% male, 80% white, 18% black, 2% Asian. Alkeran was administered at 100 mg/m2/day over 30 minutes by IV infusion for two consecutive days (Day -3 and Day -2) prior to ASCT (Day 0).

The objective of the trial was to determine the overall safety and toxicity profile of 200 mg/m2 of Alkeran in patients with multiple myeloma undergoing ASCT. The efficacy was evaluated by the International Myeloma Working Group response criteria comparing the disease response immediately prior to the ASCT procedure to the disease response assessed 90 to 100 days post-transplant. In addition, successful myeloablation, and time to engraftment were evaluated.

The overall response rate (partial response or better) improved from 79% (48 of 61) prior to the ASCT procedure to 95% (58 of 61) at 90 to 100 days post-transplant. There was also an increase in the number of patients with a stringent complete response from 0 patients prior to the ASCT procedure to 16% (10 of 61) at 90 to 100 days post-transplant.

Myeloablation and engraftment were evaluated by complete blood cell count tests daily until neutrophil and platelet engraftment, and then weekly until Day 30, and at Day 60 and Day 90-100. Myeloablation was defined as any of the following: absolute neutrophil count (ANC) < 500/mm3, absolute lymphocyte count < 100/mm3, or platelet count < 20,000/mm3). Neutrophil engraftment was defined as ANC > 500/mm3 ×3 consecutive daily assessments. Platelet engraftment was defined as untransfused platelet counts > 20,000/mm3 ×3 consecutive daily assessments. Nonengraftment was defined as failure to reach an ANC > 500/mm3 ×3 consecutive daily assessments by Day 90-100.

Myeloablation, neutrophil engraftment and platelet engraftment were achieved by all 61 patients. Myeloablation occurred on ASCT Day 5 (range ASCT days -1 to 6) with the median time to myeloablation from dosing of 8 days. The median time to neutrophil engraftment was 12 days (range ASCT days 10 to 16). The median time to platelet engraftment was 13 days (range ASCT days 10 to 28).

14.2 Palliative Treatment of Patients with Multiple Myeloma

A randomized trial compared prednisone plus IV Alkeran to prednisone plus oral Alkeran in the treatment of multiple myeloma. As discussed below, Overall Response Rates at Week 22 were comparable; however, because of changes in trial design, conclusions as to the relative activity of the 2 formulations after Week 22 are impossible to make.

Both arms received oral prednisone starting at 0.8 mg/kg/day with doses tapered over 6 weeks. Alkeran doses in each arm were:


One hundred seven patients were randomized to the oral Alkeran arm and 203 patients to the IV Alkeran arm. More patients had a poor-risk classification (58% versus 44%) and high tumor load (51% versus 34%) on the oral arm compared to the IV arm (P<0.04). Response rates at Week 22 are shown in the following table:


Initial Arm


Evaluable Patients


Responders n (%)


P


Oral Alkeran


100


44 (44%)


P>0.2


IV Alkeran


195


74 (38%)


Because of changes in protocol design after Week 22, other efficacy parameters such as Response Duration and Survival could not be compared.

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Alkeran is supplied in a single carton containing one 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 Alkeran free base equivalent to 56 mg Alkeran hydrochloride.

NDC 68152-109-00: Individual carton of Alkeran 20 mL single-dose vial containing 50 mg Alkeran free base.

16.2 Storage and Handling

Store Alkeran at room temperature 25°C (77°F). Temperature excursions are permitted between 15-30°C (59-86°F).

Alkeran is light sensitive. Retain in original carton until use.

Alkeran is a cytotoxic drug. Follow special handling and disposal procedure .

17 PATIENT 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


Mucositis


Nausea, Vomiting and Diarrhea


Allergic Reactions


Secondary cancers


Birth Defects

Patient Package Insert


PATIENT INFORMATION

Alkeran (ev-ō-meh-lah)

(melphalan) for injection, for intravenous use


What is Alkeran?

Alkeran is a prescription medicine used in people with a type of cancer called multiple myeloma:

  • before receiving a stem cell transplant (conditioning treatment)
  • as a part of care to support symptom relief (palliative treatment), in people who cannot take medicine by mouth

It is not known if Alkeran is safe and effective in children.


Do not receive Alkeran if you are allergic to Alkeran or any of the ingredients in Alkeran. See the end of this leaflet for a complete list of ingredients in Alkeran.


Before you receive Alkeran, tell your doctor 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. Alkeran can harm your unborn baby. You should not become pregnant during and after treatment with Alkeran. Tell your doctor right away if you become pregnant during treatment with Alkeran.
    • Females who are able to become pregnant should use effective birth control during and after treatment with Alkeran. Talk with your doctor about how long to use birth control after treatment with Alkeran.
    • Males who have female partners who are able to become pregnant should use effective birth control during and after treatment with Alkeran. Talk with your doctor about how long to use birth control after treatment with Alkeran.
  • are breastfeeding or plan to breastfeed. It is not known if Alkeran passes into your breast milk. You should not breastfeed during treatment with Alkeran.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


How will I receive Alkeran?

  • Alkeran is given to you into your vein through an intravenous (IV) line over 15 to 30 minutes.
  • Your doctor will do blood tests before and during your treatment with Alkeran.
  • Your doctor may prescribe medicines to help prevent nausea.

What are the possible side effects of Alkeran?

Alkeran may cause serious side effects, including:

  • Low blood cell counts are common with Alkeran and can be serious. Your doctor will do blood tests as needed to check your blood counts during your treatment with Alkeran.
    • Low platelet counts: Tell your doctor right away if you have unusual bleeding or bruising under your skin.
    • Low red blood cell counts: Tell your doctor if you are feeling weak, tired, or you get tired easily, you look pale, or you feel short of breath.
    • Low white blood cell counts: A low white blood cell count can cause you to get infections, which may be serious. Tell your doctor right away if you have symptoms of infection, such as fever, chills, cough, pain, or burning during urination.
  • Redness and sores of the lining of the mouth, lips, throat, stomach, and genitals (mucositis). Discomfort or pain due to mucositis may happen during treatment with Alkeran. Your doctor will tell you about ways to maintain nutrition and help control the discomfort from mucositis.
  • Nausea, vomiting, and diarrhea are common with Alkeran and can sometimes be serious. Tell your doctor if you get nausea, vomiting, or diarrhea. Your doctor may prescribe medicines to help prevent or treat these side effects.
  • Liver problems. Your doctor will check you for liver problems during treatment with Alkeran. Tell your doctor right away if you get any of the following signs or symptoms:

ᴼ yellowing of your skin or the whites of your eyes ᴼ severe nausea or vomiting

ᴼ pain on the right side of your stomach-area (abdomen) ᴼ dark urine (tea colored)

  • Allergic reactions. Tell your doctor right away if you get any of the following signs or symptoms:

ᴼ skin reactions, including welts, rash, itching, and ᴼ feel lightheaded or dizzy

redness ᴼ blurry vision

ᴼ fast heartbeat ᴼ swelling of your face, tongue, or throat

ᴼ shortness of breath or trouble breathing

  • Secondary cancers. New cancers have happened in people who have been treated with Alkeran.
  • Infertility. Alkeran may cause fertility problems in males and females. Talk to your doctor if this is a concern for you.

The most common side effects of Alkeran include tiredness and low potassium level.

These are not all the possible side effects of Alkeran. 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 Alkeran.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Alkeran for a condition for which it was not prescribed. Do not give Alkeran to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Alkeran that is written for health professionals.


What are the ingredients in Alkeran?

Active ingredient: Alkeran hydrochloride

Inactive ingredient: Betadex Sulfobutyl Ether Sodium

Manufactured for: Spectrum Pharmaceuticals, Inc. Irvine, CA 92618

For more information, go to www.evomela.com or call 1-888-292-9617.



Manufactured for:

Spectrum Pharmaceuticals, Inc.

Irvine, CA 92618

Alkeran Carton Label

NDC 68152-109-00

Alkeran® (melphalan) for Injection

50 mg per vial*

For Intravenous Infusion Only

Single-Use Vial

Discard Unused Portion

Sterile

*Each vial contains 50 mg Alkeran free base equivalent to 56 mg Alkeran hydrochloride.

Spectrum Pharmaceuticals

Alkeran Vial Label

NDC 68152-109-00

Alkeran® (melphalan) for Injection

50 mg per vial*

For Intravenous Infusion Only

Single-Use Vial Discard Unused Portion

Sterile

*Each vial contains 50 mg Alkeran free base equivalent to 56 mg Alkeran hydrochloride.

Rx only

Alkeran pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Alkeran available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Alkeran destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Alkeran Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Alkeran pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MELPHALAN HYDROCHLORIDE KIT [MYLAN INSTITUTIONAL LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."MELPHALAN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "melphalan". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Alkeran?

Depending on the reaction of the Alkeran after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Alkeran not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Alkeran addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Alkeran, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Alkeran consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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