Selinexor

Selinexor is a prescription medication used for the treatment of Multiple Myeloma (MM) and Diffuse Llarge B-cell Lymphoma.

• Selinexor is available under the following different brand names: Xpovio.

Adult dosage

Tablet

• 20 mg
• 40 mg
• 50 mg
• 60 mg

Multiple Myeloma

Adult dosage

• In combination with bortezomib and dexamethasone (SVd)
  • 35-day cycle
    • Selinexor 100 mg orally every Week on Day 1; continue until disease progression or unacceptable toxicity.
    • Bortezomib 1.3 mg/m2 subcutaneously every week on the day of each week for 4 weeks followed by 1 week off.
    • Dexamethasone 20 mg orally twice weekly on Days 1 and 2 of each week
    • Refer to the prescribing information of bortezomib and dexamethasone for additional dosing information.
• In combination with dexamethasone (Sd)
  • Selinexor 80 mg orally plus dexamethasone 20 mg orally on Days 1 and 3 of each week
  • Continue until disease progression or unacceptable toxicity.
  • Refer to the prescribing information of dexamethasone for additional dosing information.
• Diffuse Large B-Cell Lymphoma
• Adult dosage
  • 60 mg orally on Days 1 and 3 of each week
  • Continue until disease progression or unacceptable toxicity.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Selinexor include:

• Tiredness
• Low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath.
• Constipation
• Shortness of breath
• Increased blood sugar
• Changes in body salt and mineral levels in your blood
• Changes in kidney and liver function blood tests

Serious side effects of Selinexor include:

• Nausea and vomiting.
• Diarrhea.
• Loss of appetite and weight loss.
• Decreased sodium levels in your blood.
• Signs of infection--fever, chills, flu symptoms, cough with mucus, mouth and throat ulcers, feeling short of breath, tingly or painful blistering rash on one side of your body; or

Rare side effects of Selinexor include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Selinexor has severe interactions with no other drugs.
• Selinexor has serious interactions with at least 162 other drugs.
• Selinexor has moderate interactions with no other drugs.
• Selinexor has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Selinexor?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Selinexor?”

Cautions

• Life-threatening thrombocytopenia, potentially leading to hemorrhage may occur; monitor platelet counts at baseline and during treatment; institute platelet transfusion and/or other treatments as clinically indicated; monitor patients for signs and symptoms of bleeding and evaluate promptly; interrupt, reduce dose, or permanently discontinue based on the severity of the adverse reaction.
• Neutropenia is commonly reported, potentially increasing infection risk; obtain white blood cell counts with differential at baseline and throughout treatment; monitor more frequently during the first three months of treatment; monitor patients for signs and symptoms of concomitant infection and evaluate promptly; consider supportive measures, including antimicrobials and growth factors (. g, G-CSF); interrupt, reduce the dose or permanently discontinue based on the severity of the adverse reaction
• Nausea and/or vomiting commonly occur; follow recommendations for adequate hydration and prophylactic antiemetics; provide prophylactic antiemetics; administer 5-HT3 receptor antagonists and other anti-nausea agents before and during treatment; interrupt, reduce the dose or permanently discontinue based on the severity of adverse reaction; administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.
• Diarrhea commonly reported; monitor for dehydration and provide supportive care as required; interrupt, reduce the dose, or permanently discontinue based on the severity of adverse reaction; provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.
• Anorexia and weight loss reported; monitor weight, nutritional status, and volume status at baseline and throughout treatment; monitor more frequently during the first three months of treatment; interrupt, reduce the dose, or permanently discontinue based on the severity of adverse reaction; provide nutritional support, fluids, and electrolyte repletion as clinically indicated.
• Hyponatremia may rapidly occur (median onset 8 days) and may be severe; monitor sodium level at baseline and throughout treatment; monitor more frequently during first two months of treatment; correct sodium levels for concurrent hyperglycemia (serum glucose above 150 mg/dL) and high serum paraprotein levels; assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review; interrupt, reduce the dose or permanently discontinue based on the severity of the adverse reaction.
• Serious and fatal infections reported; most infections were not associated with neutropenia and were caused by non-opportunistic organisms; monitor for signs and symptoms of infection, evaluate, and treat promptly.
• Neurological toxicity may occur, including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confused state); advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurological toxicity fully resolves; optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes; institute fall precautions as appropriate
• Embryofoetal toxicity can occur.
  • New onset or exacerbation of cataracts has occurred; median time to new onset was 228 days and 237 days for worsening of cataract in patients with cataracts at the start of therapy; treatment usually requires surgical removal of the cataract.

Pregnancy and Lactation

• Based on animal studies and its mechanism of action, Selinexor can cause fetal harm if administered to pregnant women
• Verify the pregnancy status of females of reproductive potential before initiating Selinexor.
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose.
  • Males with a female partner of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose.
• Infertility
  • Based on animal studies, Selinexor may impair fertility in females and males
• Lactation
  • No data are available regarding the presence of Selinexor or its metabolites in human milk, or their effects on the breastfed child or milk production.
  • Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 1 week after the last dose.