Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Velcade 1mg:
Velcade 1mg is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.
Overdose of Velcade 1mg in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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There is no known specific antidote for Velcade 1mg overdosage. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which were associated with the acute onset of symptomatic hypotension (5.2) and thrombocytopenia (5.7). In the event of an overdosage, the patient's vital signs should be monitored and appropriate supportive care given.
Studies in monkeys and dogs showed that intravenous Velcade 1mg doses as low as 2 times the recommended clinical dose on a mg/m2 basis were associated with increases in heart rate, decreases in contractility, hypotension, and death. In dog studies, a slight increase in the corrected QT interval was observed at doses resulting in death. In monkeys, doses of 3 mg/m2 and greater (approximately twice the recommended clinical dose) resulted in hypotension starting at 1 hour post-administration, with progression to death in 12 to 14 hours following drug administration.
What should I avoid while taking Velcade 1mg?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Avoid becoming dehydrated if you have any vomiting or diarrhea. Symptoms of dehydration include dizziness, dry mouth, fainting, or hot and dry skin. Talk with your doctor about how best to keep yourself hydrated.
Velcade 1mg warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Peripheral Neuropathy
Velcade 1mg treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with Velcade 1mg. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness.
Patients experiencing new or worsening peripheral neuropathy during Velcade 1mg therapy may require a decrease in the dose and/or a less dose-intense schedule. In the Velcade 1mg versus dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥ Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.
Hypotension
The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.
Cardiac Toxicity
Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during Velcade 1mg therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease should be closely monitored. In the relapsed multiple myeloma study of Velcade 1mg versus dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the Velcade 1mg and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤ 1% for each individual reaction in the Velcade 1mg group. In the dexamethasone group the incidence was ≤ 1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.
Pulmonary Toxicity
Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration have occurred in patients receiving Velcade 1mg. Some of these events have been fatal.
In a clinical trial, the first two patients given high-dose cytarabine (2g/m2 per day) by continuous infusion with daunorubicin and Velcade 1mg for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy.
There have been reports of pulmonary hypertension associated with Velcade 1mg administration in the absence of left heart failure or significant pulmonary disease.
In the event of new or worsening cardiopulmonary symptoms, consider interrupting Velcade 1mg until a prompt and comprehensive diagnostic evaluation is conducted.
Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving Velcade 1mg. PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue Velcade 1mg. The safety of reinitiating Velcade 1mg therapy in patients previously experiencing PRES is not known.
Gastrointestinal Toxicity
Velcade 1mg treatment can cause nausea, diarrhea, constipation, and vomiting sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt Velcade 1mg for severe symptoms.
Thrombocytopenia/Neutropenia
Velcade 1mg is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remain consistent in the studies of multiple myeloma and mantle cell lymphoma, with no evidence of cumulative thrombocytopenia or neutropenia in the treatment regimens studied.
Monitor complete blood counts (CBC) frequently during treatment with Velcade 1mg. Measure platelet counts prior to each dose of Velcade 1mg. Adjust dose/schedule for thrombocytopenia. Gastrointestinal and intracerebral hemorrhage has occurred during thrombocytopenia in association with Velcade 1mg. Support with transfusions and supportive care, according to published guidelines.
In the single-agent, relapsed multiple myeloma study of Velcade 1mg versus dexamethasone, the mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia related to pretreatment platelet count is shown in Table 6. The incidence of bleeding (≥ Grade 3) was 2% on the Velcade 1mg arm and was < 1% in the dexamethasone arm.
Table 6: Severity of Thrombocytopenia Related to Pretreatment Platelet Count in the Relapsed Multiple Myeloma Study of Velcade 1mg versus Dexamethasone
*A baseline platelet count of 50,000/μL was required for study eligibility
**Data were missing at baseline for 1 patient
Pretreatment
Platelet Count*
Number of Patients (N=331)**
Number (%) of Patients with Platelet Count
< 10,000/μL
Number (%) of Patients with Platelet Count 10,000 to 25,000/μL
≥ 75,000/μL
309
8 (3%)
36 (12%)
≥ 50,000/μL to < 75,000/μL
14
2 (14%)
11 (79%)
≥ 10,000/μL to < 50,000/μL
7
1 (14%)
5 (71%)
Tumor Lysis Syndrome
Tumor lysis syndrome has been reported with Velcade 1mg therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions.
Hepatic Toxicity
Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt Velcade 1mg therapy to assess reversibility. There is limited re-challenge information in these patients.
Embryo-fetal Toxicity
Based on the mechanism of action and findings in animals, Velcade 1mg for Injection can cause fetal harm when administered to a pregnant woman. Velcade 1mg administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.
Females of reproductive potential should avoid becoming pregnant while being treated with Velcade 1mg for Injection. Advise females of reproductive potential that they must use contraception during treatment with Velcade 1mg for Injection and for 7 months following cessation of therapy. Advise males with female sexual partners of reproductive potential that they must use contraception during treatment with Velcade 1mg for Injection and for 4 months following cessation of therapy. If Velcade 1mg for Injection is used during pregnancy or if the patient becomes pregnant during Velcade 1mg for Injection treatment, the patient should be apprised of the potential risk to the fetus.
What should I discuss with my healthcare provider before taking Velcade 1mg?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Velcade 1mg, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Velcade 1mg or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Velcade 1mg injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Velcade 1mg injection in the elderly.
Pregnancy
Pregnancy Category
Explanation
All Trimesters
D
Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving Velcade 1mg, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Velcade 1mg with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Fosphenytoin
Phenobarbital
Phenytoin
Rifabutin
Rifapentine
St John's Wort
Using Velcade 1mg with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Itraconazole
Ketoconazole
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Velcade 1mg. Make sure you tell your doctor if you have any other medical problems, especially:
Allergy to boron or
Allergy to mannitol—Should not be used in patients with these conditions.
Syncope (fainting), history of—Use with caution. May make these conditions worse.
Herpes zoster (shingles)—May reactivate this condition.
Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Velcade 1mg precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Peripheral Neuropathy
Velcade 1mg treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with Velcade 1mg. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness.
Patients experiencing new or worsening peripheral neuropathy during Velcade 1mg therapy may require a decrease in the dose and/or a less dose-intense schedule. In the Velcade 1mg versus dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥ Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.
Hypotension
The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.
Cardiac Toxicity
Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during Velcade 1mg therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease should be closely monitored. In the relapsed multiple myeloma study of Velcade 1mg versus dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the Velcade 1mg and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤ 1% for each individual reaction in the Velcade 1mg group. In the dexamethasone group the incidence was ≤ 1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.
Pulmonary Toxicity
Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration have occurred in patients receiving Velcade 1mg. Some of these events have been fatal.
In a clinical trial, the first two patients given high-dose cytarabine (2g/m2 per day) by continuous infusion with daunorubicin and Velcade 1mg for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy.
There have been reports of pulmonary hypertension associated with Velcade 1mg administration in the absence of left heart failure or significant pulmonary disease.
In the event of new or worsening cardiopulmonary symptoms, consider interrupting Velcade 1mg until a prompt and comprehensive diagnostic evaluation is conducted.
Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving Velcade 1mg. PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue Velcade 1mg. The safety of reinitiating Velcade 1mg therapy in patients previously experiencing PRES is not known.
Gastrointestinal Toxicity
Velcade 1mg treatment can cause nausea, diarrhea, constipation, and vomiting sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt Velcade 1mg for severe symptoms.
Thrombocytopenia/Neutropenia
Velcade 1mg is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remain consistent in the studies of multiple myeloma and mantle cell lymphoma, with no evidence of cumulative thrombocytopenia or neutropenia in the treatment regimens studied.
Monitor complete blood counts (CBC) frequently during treatment with Velcade 1mg. Measure platelet counts prior to each dose of Velcade 1mg. Adjust dose/schedule for thrombocytopenia. Gastrointestinal and intracerebral hemorrhage has occurred during thrombocytopenia in association with Velcade 1mg. Support with transfusions and supportive care, according to published guidelines.
In the single-agent, relapsed multiple myeloma study of Velcade 1mg versus dexamethasone, the mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia related to pretreatment platelet count is shown in Table 6. The incidence of bleeding (≥ Grade 3) was 2% on the Velcade 1mg arm and was < 1% in the dexamethasone arm.
Table 6: Severity of Thrombocytopenia Related to Pretreatment Platelet Count in the Relapsed Multiple Myeloma Study of Velcade 1mg versus Dexamethasone
*A baseline platelet count of 50,000/μL was required for study eligibility
**Data were missing at baseline for 1 patient
Pretreatment
Platelet Count*
Number of Patients (N=331)**
Number (%) of Patients with Platelet Count
< 10,000/μL
Number (%) of Patients with Platelet Count 10,000 to 25,000/μL
≥ 75,000/μL
309
8 (3%)
36 (12%)
≥ 50,000/μL to < 75,000/μL
14
2 (14%)
11 (79%)
≥ 10,000/μL to < 50,000/μL
7
1 (14%)
5 (71%)
Tumor Lysis Syndrome
Tumor lysis syndrome has been reported with Velcade 1mg therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions.
Hepatic Toxicity
Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt Velcade 1mg therapy to assess reversibility. There is limited re-challenge information in these patients.
Embryo-fetal Toxicity
Based on the mechanism of action and findings in animals, Velcade 1mg for Injection can cause fetal harm when administered to a pregnant woman. Velcade 1mg administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.
Females of reproductive potential should avoid becoming pregnant while being treated with Velcade 1mg for Injection. Advise females of reproductive potential that they must use contraception during treatment with Velcade 1mg for Injection and for 7 months following cessation of therapy. Advise males with female sexual partners of reproductive potential that they must use contraception during treatment with Velcade 1mg for Injection and for 4 months following cessation of therapy. If Velcade 1mg for Injection is used during pregnancy or if the patient becomes pregnant during Velcade 1mg for Injection treatment, the patient should be apprised of the potential risk to the fetus.
What happens if I miss a dose of Velcade 1mg?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Call your doctor for instructions if you will miss an appointment for your Velcade 1mg injection.
References
DailyMed. "BORTEZOMIB: 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/dailyme... (accessed September 17, 2018).
