DRUGS & SUPPLEMENTS
Vincasar PFS uses
1 INDICATIONS AND USAGE
Vincasar PFS is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified (1.1).
1.1 Adult ALL in Second or Greater Relapse
Vincasar PFS® is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.
2 DOSAGE AND ADMINISTRATION
For Intravenous Use Only. Fatal if Given by Other Routes.
Vincasar PFS has different dosage recommendations than Vincasar PFS injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.
Intravenous use only. Do not administer by any other route (2)
Administer Vincasar PFS at a dose of 2.25 mg/m2 intravenously over 1 hour once every 7 days (2.1).
2.1 Recommended Dosage
The recommended dose of Vincasar PFS is 2.25 mg/m2 intravenously over 1 hour once every 7 days.
Vincasar PFS is liposome-encapsulated vincristine.
2.2 Dose modifications: Peripheral Neuropathy
Vincasar PFS is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome [see Contraindications ]. Patients with preexisting severe neuropathy should be treated with Vincasar PFS only after careful risk-benefit assessment [see Warnings and Precautions (5.3) ]. For dose or schedule modifications guidelines for patients who experience peripheral neuropathy, see Table 1.
2.3 Preparation and Handling
Procedures for handling and disposal of anticancer drugs should be followed [see References (15) ].
Call [1 888 292 9617] if you have questions about the preparation of Vincasar PFS. Vincasar PFS takes approximately 60 to 90 minutes to prepare. The preparer should have dedicated uninterrupted time to prepare Vincasar PFS due to the extensive monitoring of temperature and time required for the preparation.
Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Vincasar PFS. The preparation steps of Vincasar PFS that involve mixing the Sodium Phosphate Injection, Sphingomyelin/Cholesterol Liposome Injection, and Vincasar PFS Injection must be done in a biological safety cabinet or by established pharmacy safety procedures for the preparation of sterile injectable formulations and hazardous drugs. However, the preparation steps that involve placement of the vial in the water bath must be done outside of the sterile area.
Do not use with in-line filters. Do not mix with other drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.
Note: Do NOT use water with the block heater preparation process.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.
3 DOSAGE FORMS AND STRENGTHS
Vincasar PFS is prepared from the components in the Vincasar PFS Kit. Following the preparation procedure according to section 2.3.2, each single-dose vial of Vincasar PFS (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) Vincasar PFS.
The final drug product is prepared on site from the components in the Vincasar PFS Kit. After preparation, each single-dose vial of Vincasar PFS (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) Vincasar PFS (2.3.2).
Vincasar PFS is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome.
Vincasar PFS is contraindicated in patients with hypersensitivity to Vincasar PFS or any of the other components of Vincasar PFS (vinCRIStine sulfate LIPOSOME injection).
Vincasar PFS is contraindicated for intrathecal administration.
5 WARNINGS AND PRECAUTIONS
5.1 For Intravenous Use Only
Fatal if Given by Other Routes. Death has occurred with intrathecal use.
5.2 Extravasation Tissue Injury
Only administer through a secure and free-flowing venous access line. If extravasation is suspected, discontinue infusion immediately and consider local treatment measures.
5.3 Neurologic Toxicity
Sensory and motor neuropathies are common and are cumulative. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, hyporeflexia, areflexia, neuralgia, jaw pain, decreased vibratory sense, cranial neuropathy, ileus, burning sensation, arthralgia, myalgia, muscle spasm, or weakness, both before and during treatment. Orthostatic hypotension may occur. The risk of neurologic toxicity is greater if Vincasar PFS is administered to patients with preexisting neuromuscular disorders or when other drugs with risk of neurologic toxicity are being given. In the studies of relapsed and/or refractory adult ALL patients, Grade ≥ 3 neuropathy events occurred in 32.5% of patients. Worsening neuropathy requires dose delay, reduction, or discontinuation of Vincasar PFS [see Dosage and Administration ].
Monitor complete blood counts prior to each dose of Vincasar PFS. If Grade 3 or 4 neutropenia, thrombocytopenia, or anemia develops, consider Vincasar PFS dose modification or reduction as well as supportive care measures.
5.5 Tumor Lysis Syndrome
Tumor lysis syndrome may occur in patients with ALL receiving Vincasar PFS. Anticipate, monitor for, and manage.
5.6 Constipation and Bowel Obstruction
Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred. Vincasar PFS can cause constipation [see Adverse Reactions (6) ]. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction, and/or paralytic ileus, considering adequate dietary fiber intake, hydration, and routine use of stool softeners, such as docusate. Additional treatments, such as senna, bisacodyl, milk of magnesia, magnesium citrate, and lactulose may be considered.
Vincasar PFS can cause severe fatigue. Vincasar PFS dose delay, reduction, or discontinuation may be necessary.
5.8 Hepatic Toxicity
Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred. Elevated levels of aspartate aminotransferase of Grade ≥3 occurred in 6-11% of patients in clinical trials. Monitor hepatic function tests. Reduce or interrupt Vincasar PFS for hepatic toxicity.
5.9 Embryofetal Toxicity
Vincasar PFS can cause fetal harm when administered to a pregnant woman. Vincasar PFS liposome injection was teratogenic or caused embryo-fetal death in animals. Women of childbearing potential should avoid becoming pregnant while being treated with Vincasar PFS. There are no adequate and well-controlled studies of Vincasar PFS in pregnant women and there were no reports of pregnancy in any of the clinical studies in the Vincasar PFS clinical development program. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus .
6 ADVERSE REACTIONS
The following adverse reactions are also discussed in other sections of the labeling:
Most commonly reported adverse reactions (incidence ≥ 30%) in clinical studies include constipation, nausea, pyrexia, fatigue, peripheral neuropathy, febrile neutropenia, diarrhea, anemia, decreased appetite, and insomnia (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Talon Therapeutics at 1-888 292 9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Safety Experience
Because clinical trials 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 trials of another drug and may not reflect the rates observed in clinical practice.
Integrated Summary of Safety in Relapsed and/or Refractory Ph- Adult Acute Lymphoblastic Leukemia
Vincasar PFS, at a dose of 2.25 mg/m2 weekly, was studied in a total of 83 patients in two trials: study 1 and study 2. Adverse reactions were observed in 100% of patients. The most common adverse reactions (>30%) were constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%).
Adverse reactions of Grade 3 or greater were reported in 96% of patients. Adverse reactions of Grade 3 or greater and occurring in ≥ 5% of patients are summarized in Table 2.
A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%).
Dose reduction, delay, or omission occurred in 53% of patients during the treatment.
Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most common adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%).
Adverse reactions related to neuropathy and leading to treatment discontinuation were decreased vibratory sense, facial palsy, hyporeflexia, constipation, asthenia, fatigue, and musculoskeletal pain, each reported in at least 1 patient.
Deaths occurred in 23% of patients in study 1. The non-leukemia related causes of deaths were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multi system organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1).
7 DRUG INTERACTIONS
No formal drug interaction studies have been conducted with Vincasar PFS. Vincasar PFS is expected to interact with drugs known to interact with non-liposomal Vincasar PFS.
Simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included non-liposomal Vincasar PFS have been reported to reduce blood levels of phenytoin and to increase seizure activity.
Vincasar PFS is expected to interact with drugs known to interact with non-liposomal Vincasar PFS.
7.1 CYP3A Interactions
Vincasar PFS, the active agent in Vincasar PFS, is a substrate for cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant use of strong CYP3A inhibitors should be avoided (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). Similarly, the concomitant use of strong CYP3A inducers should be avoided (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's Wort).
7.2 P-glycoprotein Interactions
Vincasar PFS, the active agent in Vincasar PFS, is also a substrate for P-glycoprotein (P-gp). The effect of concomitant use of potent P-gp inhibitors or inducers has not been investigated; it is likely that these agents will alter the pharmacokinetics or pharmacodynamics of Vincasar PFS. Therefore the concomitant use of potent P-gp inhibitors or inducers should be avoided.
8 USE IN SPECIFIC POPULATIONS
Pediatric Use: The safety and effectiveness of Vincasar PFS in pediatric patients has not been established
Pregnancy Category D [see Warnings and Precautions (5.9) ]
Based on its mechanism of action and findings from animal studies, Vincasar PFS can cause fetal harm when administered to pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. In an embryofetal developmental study, pregnant rats were administered Vincasar PFS liposome injection intravenously during the period of organogenesis at Vincasar PFS doses of 0.022 to 0.09 mg/kg/day. Drug-related adverse effects included fetal malformations (skeletal and visceral), decreases in fetal weights, increased numbers of early resorptions and post-implantation losses, and decreased maternal body weights Malformations were observed at doses ≥ 0.044 mg/kg/day in animals at systemic exposures approximately 20-40% of those reported in patients at the recommended dose.
8.3 Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
8.4 Pediatric Use
The safety and effectiveness of Vincasar PFS in pediatric patients have not been established.
8.5 Geriatric Use
Safety and effectiveness in elderly individuals have not been established. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
8.6 Renal Impairment
The influence of renal impairment on the safety, efficacy, and pharmacokinetics of Vincasar PFS has not been evaluated.
8.7 Hepatic Impairment
Non-liposomal Vincasar PFS is excreted primarily by the liver. The influence of severe hepatic impairment on the safety and efficacy of Vincasar PFS has not been evaluated.
The pharmacokinetics of Vincasar PFS was evaluated in patients with moderate hepatic dysfunction (Child-Pugh B) secondary to melanoma liver metastases. The dose-adjusted maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) of Vincasar PFS in patients with moderate hepatic impairment was comparable to the Cmax and AUC of patients with ALL who had otherwise normal hepatic function.
When Vincasar PFS (vinCRIStine sulfate LIPOSOME injection) was administered at a dose of 2.4 mg/m2, severe toxicities including motor neuropathy of Grade 3, grand mal seizure of Grade 4, and elevated aspartate aminotransferase and hyperbilirubinemia of Grade 4 were reported in 1 patient each. There is no known antidote for overdosage.
Vincasar PFS (vinCRIStine sulfate LIPOSOME injection) is vincristine encapsulated in sphingomyelin/cholesterol liposomes for intravenous administration.
The active ingredient in Vincasar PFS is Vincasar PFS. Vincasar PFS is a vinca alkaloid isolated as a 1:1 sulfate salt from the periwinkle plant (Catharanthus roseus). It is a hygroscopic, white to slightly yellowish crystalline powder that is soluble in water. It has a molecular weight of 923.04 (salt form) / 824.98 (base form) and a molecular formula of C46H56N4O10 - H2SO4. The chemical name for Vincasar PFS is 22-oxovincaleukoblastine and it has the following chemical structure:
Vincristine is encapsulated in a Sphingomyelin/Cholesterol liposome. The lipid components in the liposome are sphingomyelin and cholesterol at a molar ratio of approximately 60:40 (mol:mol).
After preparation, each vial of Vincasar PFS contains 5 mg Vincasar PFS, 500 mg mannitol, 73.5 mg sphingomyelin, 29.5 mg cholesterol, 36 mg sodium citrate, 38 mg citric acid, 355 mg sodium phosphate, and 225 mg sodium chloride.
Vincasar PFS (vinCRIStine sulfate LIPOSOME injection) appears as a white to off-white, translucent suspension, essentially free of visible foreign matter and aggregates, comprised of sphingomyelin/cholesterol liposomes, with an approximate liposome mean diameter of 100 nm. Greater than 95% of the drug is encapsulated in the liposomes.
The Vincasar PFS Kit component vials for the preparation of Vincasar PFS (vinCRIStine sulfate LIPOSOME injection) include:
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Vincasar PFS is a sphingomyelin/cholesterol liposome-encapsulated formulation of Vincasar PFS. Non-liposomal Vincasar PFS binds to tubulin, altering the tubulin polymerization equilibrium, resulting in altered microtubule structure and function. Non-liposomal Vincasar PFS stabilizes the spindle apparatus, preventing chromosome segregation, triggering metaphase arrest and inhibition of mitosis.
The plasma pharmacokinetics of Vincasar PFS was investigated in 13 adult patients with relapsed ALL who received a Vincasar PFS dose of 2.25 mg/m2 administered as a 1-hour intravenous infusion. The calculated pharmacokinetic parameters for total plasma Vincasar PFS are given in Table 3. The Vincasar PFS levels reported in Table 3 reflect liposome-encapsulated drug that may not be immediately bioavailable and may not be directly comparable to plasma levels of Vincasar PFS after administration of non-liposomal Vincasar PFS, which is immediately bioavailable.
The plasma clearance (CL) of Vincasar PFS is slow, 345 mL/h, at a dose of 2.25 mg/m2. This is in comparison to the rapid clearance of non-liposomal Vincasar PFS at 189 mL/min/m2 (11,340 mL/h). The slow clearance of Vincasar PFS contributes to a much higher AUC for Vincasar PFS relative to non-liposomal Vincasar PFS.
Following intravenous administration of Vincasar PFS, urinary excretion was a minor route of elimination for Vincasar PFS and its metabolite. Less than 8% of the administered Vincasar PFS dose was eliminated in urine over a 96-hour observation period, which is similar to the urinary excretion of non-liposomal Vincasar PFS. Following non-liposomal Vincasar PFS infusion, the main route of Vincasar PFS excretion was the fecal route, accounting for 69% of the administered dose over 72 hours.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity studies have been conducted with Vincasar PFS or non-liposomal Vincasar PFS. Based on the mechanism of action and genotoxicity findings in nonclinical studies conducted with non-liposomal Vincasar PFS, Vincasar PFS may be carcinogenic.
No genotoxicity studies have been conducted with Vincasar PFS. Non-liposomal vincristine was genotoxic in some in vitro and in vivo studies.
The single- and repeat-dose animal toxicology study results indicate that Vincasar PFS can impair male fertility, consistent with the literature on non-liposomal Vincasar PFS. Administration of vincristine liposome injection causes testicular degeneration and atrophy, and epididymal aspermia in rats.
Gonadal dysfunction has been reported in both male and female post-pubertal patients who received multi-agent chemotherapy including non-liposomal Vincasar PFS. The degree to which testicular or ovarian functions are affected is age-, dose-, and agent-dependent. Recovery may occur in some but not all patients.
13.2 Animal Toxicology and/or Pharmacology
In a repeat-dose comparative toxicology study in rats, Vincasar PFS liposome injection or non-liposomal Vincasar PFS was administered to animals intravenously once per week for 6 weeks. Clinical signs of toxicity consistent with neurotoxicity were greater with Vincasar PFS liposome injection than with non-liposomal Vincasar PFS at equal Vincasar PFS doses of 2 mg/m2/week and included uncoordinated movements, weakness, reduced muscle tone, and limited usage of the limbs. Neurological testing indicated drug-induced peripheral neurotoxicity with both drugs. Based on the histopathology examination after 6 weekly doses, Vincasar PFS liposome injection induced greater peripheral neurotoxicity (nerve fiber degeneration) and secondary skeletal muscle atrophy than the equal dose of non-liposomal Vincasar PFS. In a separate tissue distribution study in rats, administration of 2 mg/m2 of intravenous liposomal or non-liposomal Vincasar PFS showed greater accumulation of Vincasar PFS in sciatic and tibial nerves (as well as the lymph nodes, spleen, and bone marrow) of the animals following Vincasar PFS liposome injection.
14 CLINICAL STUDIES
14.1 Acute Lymphoblastic Leukemia
Vincasar PFS was studied in an international, open-label, multi-center, single-arm trial (Study 1). Eligible patients were 18 years of age or older with Philadelphia chromosome negative ALL in second or greater relapse or whose disease progressed after two or greater treatment lines of anti-leukemia therapy. Patients had to have achieved a complete remission (CR) to at least one prior anti-leukemia chemotherapy, defined by a leukemia-free interval of equal or more than 90 days. Patients were not eligible for immediate hematopoietic stem cell transplantation (HSCT) at the time of screening and enrollment.
Patients received intravenous Vincasar PFS monotherapy at 2.25 mg/m2 over 60 minutes every 7 days. Concomitant corticosteroids were not permitted beyond Day 5.
The treated population included 65 patients who received at least 1 dose of Vincasar PFS. All of the treated patients had received prior Vincasar PFS and 80% had evidence of residual neuropathy at study baseline. Among treated patients, 51% were male, 86% were white, 45% were under 30 years of age, 11% were age 65 or older, 48% had undergone prior HSCT, 51% had received 3 or more prior therapies, and 45% were refractory to their immediate prior therapy. Disease characteristics were 85% precursor B-cell ALL and 15% precursor T-cell ALL. In addition, 22 of 65 (34%) treated patients did not receive asparaginase products prior to enrollment. Efficacy results are shown in Table 4.
16 HOW SUPPLIED/STORAGE AND HANDLING
The Vincasar PFS Kit contains:
Store the Vincasar PFS Kit in the refrigerator at 2°C to 8°C – Do Not Freeze
17 PATIENT COUNSELING INFORMATION
Physicians are advised to discuss the following with patients prior to treatment with Vincasar PFS:
Extravasation Tissue Injury: Advise patients to report immediately any burning or local irritation during or after the infusion [see Warnings and Precautions (5.2) ].
Ability to Drive or Operate Machinery or Impairment of Mental Ability: Vincasar PFS may cause fatigue and symptoms of peripheral neuropathy. Advise patients not to drive or operate machinery if they experience any of these symptoms [see Warnings and Precautions (5.3, 5.7) ].
Gastrointestinal/Constipation: Patients receiving Vincasar PFS may experience constipation. Advise patients how to avoid constipation by a diet high in bulk fiber, fruits and vegetables, and adequate fluid intake as well as use of a stool softener, such as docusate. Instruct patients to seek medical advice if they experience symptoms of constipation such bowel movement infrequency, abdominal pain, bloating, diarrhea, nausea, or vomiting [see Warnings and Precautions (5.6) ].
Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with Vincasar PFS [see Warnings and Precautions (5.9) ]. Instruct patients to report pregnancy to their physicians immediately. Advise patients that they should not receive Vincasar PFS while pregnant or breastfeeding. If a patient wishes to re-start breastfeeding after treatment, she should be advised to discuss the appropriate timing with her physician [see Use in Specific Populations (8.3) ].
Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking [see Drug Interactions (7) ].
Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the feet or hands [see Warnings and Precautions (5.3) ].
Other: Instruct patients to notify their physicians if they experience fever, productive cough, or decreased appetite [see Warnings and Precautions (5.4) ].
Talon Therapeutics, Inc., a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc.
157 Technology Drive
Irvine, CA 92618
Vincasar PFS 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.
Vincasar PFS 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.
Vincasar PFS 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.
Vincasar PFS 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.
Vincasar PFS 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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Vincasar PFS?
Depending on the reaction of the Vincasar PFS after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vincasar PFS 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 Vincasar PFS 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.
ReviewsDrugs.com conducted a study on Vincasar PFS, 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 Vincasar PFS 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.
The information was verified by Dr. Arunabha Ray, MD Pharmacology