Leustatine belongs to the group of medicines called antimetabolites. It is used to treat hairy cell leukemia, a cancer of the blood and bone marrow. It is also sometimes used to treat other kinds of cancer, as determined by your doctor.
Leustatine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by Leustatine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with Leustatine, you and your doctor should talk about the good Leustatine will do as well as the risks of using it.
Leustatine is to be administered only by or under the immediate supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Leustatine is used in certain patients with the following conditions:
Cancer of the blood and lymph system
Waldenström's macroglobulinemia (a certain type of cancer of the blood)
Leustatine indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Leustatine is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of Leustatine is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.
Limitations of Use
Leustatine is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
How should I use Leustatine?
Use Leustatine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Leustatine is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
Do not use Leustatine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
If Leustatine accidentally spills on your skin, wash it off right away with soap and water. Clean any areas (counters, tables) where Leustatine may have spilled or sprayed.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Leustatine, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Leustatine.
Uses of Leustatine in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Hairy cell leukemia (injection only): Treatment of active hairy cell leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Multiple sclerosis, relapsing (oral tablet only): Treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting (RRMS) and active secondary progressive disease in adults who have had inadequate response or are intolerant to other therapies for multiple sclerosis.
Limitations of use: Not recommended for patients with clinically isolated syndrome.
Off Label Uses
Acute myeloid leukemia
Data from a large multicenter randomized phase III trial support the use of Leustatine (in combination with daunorubicin and cytarabine) as induction therapy in newly diagnosed adult patients with acute myeloid leukemia (AML).
Leustatine description
An antineoplastic agent used in the treatment of lymphoproliferative diseases including hairy-cell leukemia. [PubChem]
Leustatine dosage
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Leustatine Dosage
Generic name: Leustatine 1mg in 1mL
Dosage form: injection, solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Dose
The recommended dose and schedule of Leustatine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Leustatine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs.
Specific risk factors predisposing to increased toxicity from Leustatine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity.
Preparation and Administration of
Intravenous Solutions
Leustatine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial preservative or bacteriostatic agent, aseptic technique and proper environmental precautions must be observed in preparation of Leustatine Injection solutions.
To prepare a single daily dose
Leustatine Injection should be passed through a sterile 0.22µm disposable hydrophilic syringe filter prior to introduction into the infusion bag, prior to each daily infusion. Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Leustatine Injection through the sterile filter to an infusion bag containing 500 mL of 0.9% Sodium Chloride Injection, USP. Infuse continuously over 24 hours. Repeat daily for a total of 7 consecutive days. The use of 5% dextrose as a diluent is not recommended because of increased degradation of Leustatine. Admixtures of Leustatine Injection are chemically and physically stable for at least 24 hours at room temperature under normal room fluorescent light in Baxter Viaflex®1 PVC infusion containers. Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised.
Dose of Leustatine Injection
Recommended Diluent
Quantity of Diluent
24-hour infusion method
1(day) × 0.09 mg/kg
0.9% Sodium Chloride Injection, USP
500 mL
1
Viaflex® containers, manufactured by Baxter Healthcare Corporation - Code No. 2B8013 (tested in 1991)
To prepare a 7-day infusion
The 7-day infusion solution should only be prepared with Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol preserved). In order to minimize the risk of microbial contamination, both Leustatine Injection and the diluent should be passed through a sterile 0.22 µm disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Leustatine Injection (7 days × 0.09 mg/kg or mL/kg) to the infusion reservoir through the sterile filter.
Then add a calculated amount of Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol preserved) also through the filter to bring the total volume of the solution to 100 mL. After completing solution preparation, clamp off the line, disconnect and discard the filter. Aseptically aspirate air bubbles from the reservoir as necessary using the syringe and a dry second sterile filter or a sterile vent filter assembly. Reclamp the line and discard the syringe and filter assembly. Infuse continuously over 7 days. Solutions prepared with Bacteriostatic Sodium Chloride Injection for individuals weighing more than 85 kg may have reduced preservative effectiveness due to greater dilution of the benzyl alcohol preservative. Admixtures for the 7-day infusion have demonstrated acceptable chemical and physical stability for at least 7 days in the SIMS Deltec MEDICATION CASSETTE™ Reservoir2.
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Leustatine Injection should not be mixed with other intravenous drugs or additives or infused simultaneously via a common intravenous line, since compatibility testing has not been performed. Preparations containing benzyl alcohol should not be used in neonates.
Care must be taken to assure the sterility of prepared solutions. Once diluted, solutions of Leustatine Injection should be administered promptly or stored in the refrigerator (2° to 8° C) for no more than 8 hours prior to start of administration. Vials of Leustatine Injection are for single-use only. Any unused portion should be discarded in an appropriate manner.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A precipitate may occur during the exposure of Leustatine Injection to low temperatures; it may be resolubilized by allowing the solution to warm naturally to room temperature and by shaking vigorously. DO NOT HEAT OR MICROWAVE.
2
MEDICATION CASSETTE™ Reservoir, manufactured by SIMS Deltec, Inc. - Reorder No. 602100A (tested in 1991)
Chemical Stability of Vials
When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Leustatine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Leustatine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Leustatine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal
The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Leustatine Injection. The use of disposable gloves and protective garments is recommended. If Leustatine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2–8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
Agents that Undergo Intracellular Phosphorylation: May diminish the therapeutic effect of Leustatine. Avoid combination
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCRP/ABCG2 Inducers: May decrease the serum concentration of Leustatine. Monitor therapy
BCRP/ABCG2 Inhibitors: May increase the serum concentration of Leustatine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral Leustatine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Consider therapy modification
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification
Hormonal Contraceptives: Leustatine may diminish the therapeutic effect of Hormonal Contraceptives. Management: Women using systemically acting hormonal contraceptives should add a barrier method during Leustatine dosing and for at least 4 weeks after the last dose in each treatment course. Consider therapy modification
Immunosuppressants: Leustatine may enhance the immunosuppressive effect of Immunosuppressants. Avoid combination
Inhibitors of Equilibrative Nucleoside (ENT1) and Concentrative Nucleoside (CNT3) Transport Proteins: May increase the serum concentration of Leustatine. Management: Avoid concomitant use of ENT1 or CNT3 inhibitors during the 4 to 5 day oral Leustatine treatment cycles whenever possible. If combined, consider an ENT1 or CNT3 inhibitor dose reduction and separation in the timing of administration. Consider therapy modification
Interferons (Beta): Leustatine may enhance the adverse/toxic effect of Interferons (Beta). Specifically, the risk for lymphopenia may be increased. Avoid combination
Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Myelosuppressive Agents: Leustatine may enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification
P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Leustatine. Monitor therapy
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification
Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination
The following serious adverse reactions and potential risks are discussed, or discussed in greater detail, in other sections of the labeling:
Malignancies
Risk of Teratogenicity
Lymphopenia
Infections
Hematologic Toxicity
Graft-Versus-Host Disease With Blood Transfusion
Liver Injury
Hypersensitivity
Cardiac Failure
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In the clinical trial program of Leustatine in MS, 1,976 patients received Leustatine for a total of 9,509 patient years. The mean time on study including follow-up was approximately 4.8 years, and approximately 24% of Leustatine-treated patients had approximately 8 years of time on study including follow-up. Of these, 923 patients aged 18 to 66 years received Leustatine as monotherapy at a cumulative dose of 3.5 mg per kg.
Table 2 shows adverse reactions in Study 1 with an incidence of at least 5% for Leustatine and higher than placebo. The most common (> 20%) adverse reactions reported in Study 1 are upper respiratory tract infection, headache, and lymphopenia.
Table 2 Adverse Reactions in Study 1 with an Incidence of at Least 5% for Leustatine and Higher than Placebo
Leustatine
(N=440)
%
Placebo
(N=435)
%
Upper respiratory tract infection
38
32
Headache
25
19
Lymphopenia
24
2
Nausea
10
9
Back pain
8
6
Arthralgia and arthritis
7
5
Insomnia
6
4
Bronchitis
5
3
Hypertension
5
3
Fever
5
3
Depression
5
3
Hypersensitivity
In clinical studies, 11% of Leustatine patients had hypersensitivity adverse reactions, compared to 7% of placebo patients.
Alopecia
Alopecia occurred in 3% of Leustatine-treated patients compared to 1% of placebo patients.
Myelodysplastic Syndrome
Cases of myelodysplastic syndrome have been reported in patients that had received parenteral Leustatine at a higher dosage than that approved for Leustatine. These cases occurred several years after treatment.
Herpes Meningoencephalitis
Fatal herpes meningoencephalitis occurred in one Leustatine-treated patient, at a higher dosage and longer duration of therapy than the approved Leustatine dosage and in combination with interferon beta-1a treatment.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
SJS and TEN are identified risks of parenteral Leustatine for the treatment of oncologic indications.
Seizures
In clinical studies, serious events of seizure occurred in 0.3% of Leustatine-treated patients compared to 0 placebo patients. Serious events included generalized tonic-clonic seizures and status epilepticus. It is unknown whether these events were related to the effects of multiple sclerosis alone, to Leustatine, or to a combination of both.
Do not use Leustatine if you are pregnant. It could harm the unborn baby.
Before you receive Leustatine, tell your doctor If you have liver or kidney disease or a bone marrow problem.
Leustatine can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using Leustatine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
Tell your caregivers at once if you have a serious side effect such as numbness or tingling, weakness or burning pain in your fingers or toes, lower back pain, blood in your urine, urinating less than usual, muscle weakness or tightness, pale or yellowed skin, easy bruising or bleeding, dark colored urine, or feeling like you might pass out.
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