Rasuvo 22.5mg/0.45ml Pf Inj, 4 Pens
WARNING: Severe side effects like bone marrow problems, liver problems, lung problems, and infections can happen with this drug. Some side effects may not go away and can be deadly. You must talk with the doctor about the risks of this drug. This drug may cause kidney problems in some patients. Talk with the doctor.Regular blood work and other exams will need to be done to check for side effects. Follow what the doctor has told you. Tell your doctor if you have kidney problems or extra fluid around your stomach area or lungs. The chance of side effects may be raised.Talk with your doctor if you are getting radiation. There may be more chance of harm to tissue and bone.New types of cancer have happened in people taking this drug. If you have questions, talk with the doctor.It is common to have diarrhea, upset stomach, throwing up, or mouth sores with this drug. However, sometimes these may be signs of severe and sometimes deadly stomach or bowel problems. Tell your doctor if you get any new or worsening signs. You may need to stop this drug.Severe skin reactions have happened with this drug. These have included Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions. Sometimes these have been deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; other skin irritation (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.Very bad and sometimes deadly bone marrow problems and stomach or bowel problems have happened when this drug was taken with nonsteroidal anti-inflammatory drug (NSAIDs) like ibuprofen or naproxen.Not all methotrexate products are used to treat cancer. Talk with the doctor.This drug may cause harm to an unborn baby or loss of an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant.If you or your sex partner may become pregnant, you must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you or your sex partner gets pregnant, call your doctor right away.Do not take if you are pregnant.This drug must only be used when other drugs cannot be used or have not worked. Talk with your doctor to be sure that the benefits of this drug are more than the risks. @ COMMON USES: It is used to treat some types of arthritis.It is used to treat some types of psoriasis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antimetabolite, Disease-Modifying Antirheumatic Drug (DMARD), Antineoplastic
Pharmacologic Class
Folic acid antagonist, Immunosuppressant
Pregnancy Category
Category X
FDA Approved
Jul 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Rasuvo is a medication containing methotrexate, which works by reducing inflammation and slowing down an overactive immune system. It is used to treat conditions like rheumatoid arthritis, psoriasis, and juvenile idiopathic arthritis by helping to control the disease and reduce symptoms.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Important Administration Guidelines
Do not inject the medication within 2 inches (5 cm) of the belly button.
Check the solution for cloudiness, leakage, or particles before use. If any of these conditions are present, do not use the medication.
Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
If you are unsure whether a dose was injected correctly or experience difficulty administering the dose, consult your doctor or pharmacist before using another dose.
Safe Disposal of Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box.
Do not reuse needles or other supplies.
When the disposal box is full, follow local regulations for proper disposal.
If you have questions or concerns, consult your doctor or pharmacist.
Dosing and Frequency
Your dosage and frequency of administration will be determined by your doctor based on the specific health condition being treated.
Important: This medication should never be taken daily unless prescribed for certain types of cancer. Incorrect use can lead to serious errors. Ensure you understand your dosage and administration schedule. If you are unsure, consult your doctor.
Your doctor may adjust the dosage or administration schedule based on blood work results, side effects, and the medication's effectiveness.
Handling and Storage
Handle this medication with care. Consult your doctor or pharmacist for guidance on proper handling.
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Additional Recommendations
* Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit fluid intake.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh or in the belly area. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Important Administration Guidelines
Do not inject the medication within 2 inches (5 cm) of the belly button.
Check the solution for cloudiness, leakage, or particles before use. If any of these conditions are present, do not use the medication.
Avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
If you are unsure whether a dose was injected correctly or experience difficulty administering the dose, consult your doctor or pharmacist before using another dose.
Safe Disposal of Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box.
Do not reuse needles or other supplies.
When the disposal box is full, follow local regulations for proper disposal.
If you have questions or concerns, consult your doctor or pharmacist.
Dosing and Frequency
Your dosage and frequency of administration will be determined by your doctor based on the specific health condition being treated.
Important: This medication should never be taken daily unless prescribed for certain types of cancer. Incorrect use can lead to serious errors. Ensure you understand your dosage and administration schedule. If you are unsure, consult your doctor.
Your doctor may adjust the dosage or administration schedule based on blood work results, side effects, and the medication's effectiveness.
Handling and Storage
Handle this medication with care. Consult your doctor or pharmacist for guidance on proper handling.
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Additional Recommendations
* Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit fluid intake.
Lifestyle & Tips
- Take exactly as prescribed, usually once a week. Do NOT take daily.
- Take folic acid supplementation as directed by your doctor to reduce side effects (e.g., mouth sores, nausea).
- Avoid or limit alcohol consumption due to increased risk of liver damage.
- Avoid prolonged sun exposure and use sunscreen, as methotrexate can increase sun sensitivity.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid live vaccines while on methotrexate therapy.
- Maintain good hydration.
Available Forms & Alternatives
Available Strengths:
- Rasuvo 10mg/0.2ml Pf Inj, 4 Pens
- Rasuvo 12.5mg/0.25ml Pf Inj, 4 Pens
- Rasuvo 22.5mg/0.45ml Pf Inj, 4 Pens
- Rasuvo 25mg/0.5ml Pf Inj, 4 Pens
- Rasuvo 15mg/0.3ml Pf Inj, 4 Pens
- Rasuvo 17.5mg/0.35ml Pf Inj, 4 Pens
- Rasuvo 20mg/0.4ml Pf Inj, 4 Pens
- Rasuvo 30mg/0.6ml Pf Inj, 4 Pens
- Rasuvo 7.5mg/0.15ml Pf Inj, 4 Pens
- Rasuvo 15mg Inj, 0.3ml
- Rasuvo 17.5mg Inj, 0.35ml
- Rasuvo 20mg Inj, 0.4ml
- Rasuvo 7.5mg Inj, 0.15ml
Dosing & Administration
Adult Dosing
Standard Dose:
For Rheumatoid Arthritis/Psoriasis: 7.5 mg to 20 mg once weekly, administered subcutaneously. Rasuvo 22.5mg/0.45ml is a specific dose strength.
Dose Range:
7.5 - 25 mg
Condition-Specific Dosing:
Rheumatoid Arthritis:
Initial: 7.5 mg once weekly. May gradually increase to a maximum of 20 mg once weekly. Some patients may require up to 25 mg once weekly.
Psoriasis:
Initial: 10 mg to 25 mg once weekly as a single dose, or divided into 3 doses given at 12-hour intervals over 24 hours. Dosage should be adjusted to achieve optimal clinical response, not to exceed 30 mg per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Polyarticular Juvenile Idiopathic Arthritis (pJIA): 10 mg/m² once weekly. Rasuvo is indicated for pJIA in patients 2 years of age and older.
Adolescent:
For Polyarticular Juvenile Idiopathic Arthritis (pJIA): 10 mg/m² once weekly. Rasuvo is indicated for pJIA in patients 2 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 61-80 mL/min: Consider 25% dose reduction or increased monitoring. Use with caution.
Moderate:
CrCl 31-60 mL/min: Reduce dose by 50% or avoid use. Increased risk of toxicity.
Severe:
CrCl < 30 mL/min: Contraindicated due to significant risk of severe toxicity.
Dialysis:
Methotrexate is poorly dialyzable by standard hemodialysis. Contraindicated.
Hepatic Impairment:
Mild:
Use with caution. Monitor liver function closely.
Moderate:
Avoid or use with extreme caution. Significant risk of hepatotoxicity. Consider dose reduction.
Severe:
Contraindicated in patients with severe hepatic impairment (e.g., cirrhosis, fibrosis, or significant liver enzyme abnormalities).
Pharmacology
Mechanism of Action
Methotrexate is an antimetabolite that inhibits dihydrofolate reductase (DHFR), an enzyme essential for DNA synthesis, repair, and cellular replication. By inhibiting DHFR, methotrexate prevents the reduction of dihydrofolate to tetrahydrofolate, a critical co-factor for purine and pyrimidine synthesis. This leads to the inhibition of DNA, RNA, and protein synthesis, particularly in rapidly proliferating cells. At lower doses used for autoimmune diseases, its mechanism is thought to involve inhibition of AICAR transformylase and thymidylate synthase, leading to accumulation of adenosine, which has anti-inflammatory properties, and inhibition of T-lymphocyte proliferation and cytokine production.
Pharmacokinetics
Absorption:
Bioavailability:
Subcutaneous: Approximately 80-90% (compared to IV). Oral bioavailability is variable and dose-dependent.
Tmax:
Subcutaneous: 1-2 hours
FoodEffect:
Not applicable for subcutaneous administration. Oral absorption can be affected by food.
Distribution:
Vd:
0.4-0.8 L/kg (variable, increases with higher doses)
ProteinBinding:
Approximately 50% (primarily to albumin)
CnssPenetration:
Limited at low doses; increases with higher doses and inflammation of meninges.
Elimination:
HalfLife:
Low dose (RA/Psoriasis): 3-10 hours (terminal half-life can be longer in some patients or with impaired renal function)
Clearance:
Primarily renal clearance via glomerular filtration and active tubular secretion.
ExcretionRoute:
Renal (approximately 50-90% unchanged), small amount via biliary excretion.
Unchanged:
50-90% (renal)
Pharmacodynamics
OnsetOfAction:
Rheumatoid Arthritis/Psoriasis: Clinical improvement typically seen within 3-6 weeks, with full effect potentially taking 12 weeks or longer.
PeakEffect:
Not directly applicable for chronic disease modification; refers to peak clinical response over weeks/months.
DurationOfAction:
Effects persist as long as therapy is continued; requires weekly dosing due to its mechanism and half-life.
Safety & Warnings
BLACK BOX WARNING
Methotrexate can cause severe or fatal toxic reactions. Patients should be closely monitored for bone marrow, liver, lung, and kidney toxicities. Methotrexate has been associated with fetal death and congenital abnormalities; it is contraindicated in pregnant women with non-oncologic diseases. Methotrexate can cause severe skin reactions. Methotrexate can cause tumor lysis syndrome. Methotrexate can cause opportunistic infections, including Pneumocystis jirovecii pneumonia. Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions. Concomitant administration of NSAIDs with high-dose methotrexate has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrollable bleeding
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of kidney problems: inability to urinate, changes in urine production, blood in the urine, or sudden weight gain
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin and eyes
Signs of lung or breathing problems: shortness of breath, trouble breathing, cough, or fever
Signs of nerve problems: abnormal burning, numbness, or tingling sensations; weakness; or paralysis (inability to move a body part)
Pinpoint red spots on the skin
Severe dizziness or fainting
Seizures
Confusion
Excessive sleepiness
Changes in vision
Bone pain
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision
Headache
Neck stiffness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
Decreased appetite
Hair loss
Dizziness, fatigue, or weakness
Stomach pain
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrollable bleeding
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting
Signs of kidney problems: inability to urinate, changes in urine production, blood in the urine, or sudden weight gain
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin and eyes
Signs of lung or breathing problems: shortness of breath, trouble breathing, cough, or fever
Signs of nerve problems: abnormal burning, numbness, or tingling sensations; weakness; or paralysis (inability to move a body part)
Pinpoint red spots on the skin
Severe dizziness or fainting
Seizures
Confusion
Excessive sleepiness
Changes in vision
Bone pain
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision
Headache
Neck stiffness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
Decreased appetite
Hair loss
Dizziness, fatigue, or weakness
Stomach pain
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe fatigue or weakness
- Unusual bleeding or bruising
- Signs of infection (fever, chills, persistent sore throat)
- Shortness of breath, persistent cough
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe abdominal pain
- Severe mouth sores or ulcers
- Severe skin rash or blistering
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Alcohol use disorder
+ Bone marrow disease, such as low white blood cell count, low platelet count, or anemia
+ Kidney disease
+ Liver disease
+ A weak immune system
If you are breast-feeding, please note that you should not breast-feed while taking this medication. Additionally, you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary duration of breast-feeding avoidance after completing the medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Alcohol use disorder
+ Bone marrow disease, such as low white blood cell count, low platelet count, or anemia
+ Kidney disease
+ Liver disease
+ A weak immune system
If you are breast-feeding, please note that you should not breast-feed while taking this medication. Additionally, you may need to avoid breast-feeding for a period after your last dose. Consult your doctor to determine the necessary duration of breast-feeding avoidance after completing the medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this drug affects you. Be aware that you may be more susceptible to infections, so it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
Due to the increased risk of bleeding, exercise caution to prevent injuries. Use a soft-bristled toothbrush and an electric razor for shaving.
Consult your doctor before receiving any vaccinations, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication. Additionally, discuss the consumption of alcohol with your doctor.
You may be more prone to sunburn, so it is vital to avoid exposure to direct sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to shield yourself from the sun, and continue this protection for the duration recommended by your doctor.
If you experience fluid loss, excessive sweating, vomiting, diarrhea, decreased appetite, or unusual thirst, notify your doctor promptly. Be aware that this medication can cause severe nervous system problems, which may be temporary or long-lasting and can worsen over time. In some cases, these problems may not resolve and can be fatal. If you have concerns, consult your doctor.
If you have undergone radiation therapy, inform your doctor. Elderly patients (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
This drug may affect fertility, potentially leading to infertility. It is unclear whether fertility will return to normal if this occurs. If you miss a menstrual period, have unprotected sex, or suspect that your birth control has failed, contact your doctor immediately.
Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this drug affects you. Be aware that you may be more susceptible to infections, so it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
Due to the increased risk of bleeding, exercise caution to prevent injuries. Use a soft-bristled toothbrush and an electric razor for shaving.
Consult your doctor before receiving any vaccinations, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication. Additionally, discuss the consumption of alcohol with your doctor.
You may be more prone to sunburn, so it is vital to avoid exposure to direct sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to shield yourself from the sun, and continue this protection for the duration recommended by your doctor.
If you experience fluid loss, excessive sweating, vomiting, diarrhea, decreased appetite, or unusual thirst, notify your doctor promptly. Be aware that this medication can cause severe nervous system problems, which may be temporary or long-lasting and can worsen over time. In some cases, these problems may not resolve and can be fatal. If you have concerns, consult your doctor.
If you have undergone radiation therapy, inform your doctor. Elderly patients (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.
This drug may affect fertility, potentially leading to infertility. It is unclear whether fertility will return to normal if this occurs. If you miss a menstrual period, have unprotected sex, or suspect that your birth control has failed, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe bone marrow suppression (low blood counts, leading to infection, bleeding, anemia)
- Severe mucositis (mouth sores, GI inflammation)
- Severe liver damage
- Kidney failure
What to Do:
Seek immediate medical attention. Leucovorin rescue is the primary antidote, administered as soon as possible. Hydration and urinary alkalinization may also be used. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Trimethoprim/sulfamethoxazole (Bactrim, Septra) - significantly increases methotrexate levels and toxicity
- Probenecid - inhibits renal excretion of methotrexate
- Live vaccines (during methotrexate therapy)
- Alcohol (excessive use) - increases risk of hepatotoxicity
- NSAIDs (high dose or in patients with renal impairment/dehydration) - can increase methotrexate levels and toxicity, especially with high-dose methotrexate. Caution with low-dose methotrexate, but monitor closely.
- Salicylates (e.g., aspirin) - can decrease protein binding and renal clearance of methotrexate
Major Interactions
- NSAIDs (non-steroidal anti-inflammatory drugs) - may reduce methotrexate renal clearance, leading to increased methotrexate levels and toxicity. Use with caution and monitor.
- Proton Pump Inhibitors (PPIs) - e.g., omeprazole, esomeprazole; may increase methotrexate levels, especially at higher methotrexate doses. Monitor.
- Penicillins and Cephalosporins - may decrease methotrexate renal clearance. Monitor.
- Folic acid antagonists (e.g., pyrimethamine, triamterene) - additive antifolate effects, increasing toxicity.
- Phenytoin - may decrease phenytoin levels and increase methotrexate toxicity.
- Theophylline - methotrexate may decrease theophylline clearance.
- Retinoids (e.g., acitretin, etretinate) - increased risk of hepatotoxicity.
Moderate Interactions
- Sulfonamides (other than trimethoprim/sulfamethoxazole) - may displace methotrexate from protein binding.
- Oral antibiotics (e.g., tetracyclines, chloramphenicol) - may alter gut flora, affecting methotrexate absorption/enterohepatic recirculation.
- Corticosteroids - may reduce methotrexate efficacy if given concurrently for RA/psoriasis, but often used together for initial control.
- Leflunomide - increased risk of hepatotoxicity and myelosuppression when combined.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To establish baseline hematologic status and detect pre-existing myelosuppression.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - AST, ALT, alkaline phosphatase, bilirubin, albumin
Rationale: To establish baseline liver function and detect pre-existing hepatic impairment.
Timing: Prior to initiation of therapy
Renal Function Tests - Serum creatinine, BUN, eGFR
Rationale: To establish baseline renal function, as methotrexate is primarily renally cleared.
Timing: Prior to initiation of therapy
Chest X-ray
Rationale: To rule out pre-existing pulmonary disease, as methotrexate can cause pulmonary toxicity.
Timing: Prior to initiation of therapy
Hepatitis B and C serology
Rationale: To screen for chronic viral hepatitis, which can increase risk of methotrexate-induced hepatotoxicity.
Timing: Prior to initiation of therapy
Routine Monitoring
Complete Blood Count (CBC) with differential and platelets
Frequency: Every 2-4 weeks for the first 3 months, then every 1-2 months thereafter, or as clinically indicated.
Target: WBC > 3.5 x 10^9/L, Neutrophils > 1.5 x 10^9/L, Platelets > 100 x 10^9/L
Action Threshold: Hold dose for significant drops (e.g., WBC < 3.0, ANC < 1.0, Platelets < 75-100). Consider dose reduction or discontinuation.
Liver Function Tests (LFTs) - AST, ALT, alkaline phosphatase, bilirubin, albumin
Frequency: Every 2-4 weeks for the first 3 months, then every 1-2 months thereafter, or as clinically indicated.
Target: AST/ALT < 2x ULN (Upper Limit of Normal)
Action Threshold: Hold dose if AST/ALT > 2x ULN. If persistent, consider liver biopsy or discontinuation. Discontinue if persistent elevation > 3x ULN.
Renal Function Tests - Serum creatinine, BUN, eGFR
Frequency: Every 1-2 months, or as clinically indicated.
Target: Within normal limits for age/sex
Action Threshold: Hold dose or reduce if creatinine increases significantly or eGFR decreases. Discontinue if CrCl < 30 mL/min.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat)
- Unusual bleeding or bruising
- Fatigue, weakness (signs of anemia)
- Shortness of breath, cough (signs of pulmonary toxicity)
- Yellowing of skin or eyes, dark urine, abdominal pain (signs of liver toxicity)
- Oral sores, stomatitis, diarrhea (signs of GI toxicity)
- Skin rash, photosensitivity
Special Patient Groups
Pregnancy
Contraindicated in pregnant women with non-oncologic diseases due to significant risk of fetal death and severe congenital abnormalities. Women of childbearing potential must use effective contraception during and for at least 6 months after therapy.
Trimester-Specific Risks:
First Trimester:
High risk of major congenital malformations (e.g., craniofacial, limb, cardiovascular defects) and spontaneous abortion.
Second Trimester:
Risk of fetal death and growth restriction.
Third Trimester:
Risk of fetal death and growth restriction.
Lactation
Contraindicated. Methotrexate is excreted into breast milk and can cause serious adverse reactions in a breastfed infant.
Infant Risk:
High risk of myelosuppression, immunosuppression, and other toxicities.
Pediatric Use
Rasuvo is indicated for polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older. Dosing is weight/body surface area-based. Close monitoring for toxicity is essential, similar to adults.
Geriatric Use
Use with caution. Elderly patients may have decreased renal function, which can lead to increased methotrexate levels and toxicity. Increased risk of myelosuppression and other adverse effects. Close monitoring of renal function and blood counts is crucial.
Clinical Information
Clinical Pearls
- Methotrexate is dosed WEEKLY, not daily. Daily dosing for non-oncologic indications can be fatal.
- Folic acid supplementation (usually 1-5 mg once daily, or 24 hours after methotrexate dose) is crucial to mitigate common side effects like nausea, stomatitis, and liver enzyme elevations, without significantly reducing efficacy.
- Patients should be educated on the importance of avoiding alcohol due to the risk of hepatotoxicity.
- Regular monitoring of CBC, LFTs, and renal function is mandatory and should not be skipped.
- Patients should be advised to report any signs of infection, unusual bleeding/bruising, or respiratory symptoms immediately.
- Ensure patients understand the subcutaneous injection technique and proper disposal of pens.
Alternative Therapies
- Other conventional synthetic DMARDs (csDMARDs): Hydroxychloroquine, Sulfasalazine, Leflunomide
- Biologic DMARDs (bDMARDs): TNF inhibitors (e.g., Adalimumab, Etanercept, Infliximab), IL-6 inhibitors (e.g., Tocilizumab), T-cell costimulation modulators (e.g., Abatacept), B-cell depleting agents (e.g., Rituximab)
- Targeted Synthetic DMARDs (tsDMARDs): JAK inhibitors (e.g., Tofacitinib, Baricitinib, Upadacitinib)
Cost & Coverage
Average Cost:
Varies significantly by pharmacy and insurance plan. For Rasuvo 22.5mg/0.45ml, expect several hundred to over a thousand dollars per pack of 4 pens. per 4 pens
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.