Usage
Mycobacterium w (Mw), also known as Mycobacterium indicus pranii, is an immunotherapeutic agent primarily used in the treatment of leprosy, particularly in lepromin-negative patients. It is also used as an adjuvant therapy in patients with advanced non-small cell lung cancer (NSCLC) undergoing chemotherapy with paclitaxel and cisplatin, and for the treatment of sepsis.
Alternate Names
- Mycobacterium indicus pranii
- Sepsivac (brand name)
How It Works
Mycobacterium w is a heat-killed preparation of the bacterium. Its mechanism of action involves modulating the host’s immune response. Specifically, it acts as a toll-like receptor (TLR)-2 agonist, stimulating innate immunity and reducing the inflammatory response. It is thought to enhance bacterial clearance and restore immune system function, especially in immunocompromised individuals. Pharmacokinetic studies on its absorption, distribution, metabolism and excretion haven’t been widely conducted as it is administered intradermally by a healthcare professional, primarily in hospital settings. Information regarding receptor binding, enzyme inhibition, or neurotransmitter modulation is not available in the provided literature.
Dosage
Standard Dosage
Adults:
- Leprosy: 0.1 mL intradermally in the deltoid region of each arm initially, followed by 0.1 mL in one deltoid region every 3 months for 2 years (total 8 doses) along with multi-drug therapy (MDT).
- NSCLC: 0.2 mL intradermally (0.1 mL in each arm) one week before chemotherapy initiation, followed by 0.1 mL in the deltoid region during the 2nd and 3rd week of each chemotherapy cycle (Paclitaxel and Cisplatin) for a total of four cycles. Continue monthly administration until 12 months from treatment start.
- Severe Sepsis: 0.3 mL intradermally (0.1 mL in three different sites) daily for three days (total 0.9 mL). Recommended age range is 18-65 years.
Children:
Pediatric dosage information is not explicitly mentioned in the provided literature.
Special Cases:
- Elderly Patients: Dosage adjustments are not specifically mentioned in the provided literature, although intravenous administration has been found to be safe in elderly patients with sepsis.
- Patients with Renal/Hepatic Impairment: Dosage modifications haven’t been provided in the current sources.
- Patients with Comorbid Conditions: Contraindicated in patients undergoing chemotherapy other than the recommended regimen for NSCLC. Caution advised in patients with skin conditions. Choose a site free from lesions if eczema exists.
Clinical Use Cases
Dosage recommendations for specific clinical settings like intubation, surgical procedures, mechanical ventilation, and ICU use, beyond sepsis, have not been provided in the given literature.
Dosage Adjustments
Specific dosage adjustments based on individual patient factors have not been mentioned in the provided literature.
Side Effects
Common Side Effects
Injection site reactions: erythema, induration, ulceration, nodule formation, local hypersensitivity. Systemic effects: Nausea, vomiting, diarrhea, pain, weakness, loss of appetite.
Rare but Serious Side Effects
Large ulcers, abscesses at the injection site (mostly due to improper injection technique), generalized granulomatous dermatitis.
Long-Term Effects
Atrophic scarring at the injection site.
Adverse Drug Reactions (ADR)
Anaphylactic reactions, though rare, have been reported.
Contraindications
- History of allergic reactions to Mycobacterium w or its excipients.
- Fever.
- Pregnancy and breastfeeding.
- Generalized septic skin conditions.
- Chronic debilitating conditions other than the indicated conditions.
- Concurrent chemotherapy (other than the specified regimen for NSCLC).
Drug Interactions
No significant drug-drug interactions have been reported. It has been administered concurrently with cytotoxic and anti-leprosy drugs without known interactions.
Pregnancy and Breastfeeding
Contraindicated in pregnancy and breastfeeding. It is unknown if Mycobacterium w is excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Immunomodulator, TLR-2 agonist.
- Side Effects: Injection site reactions, gastrointestinal issues, hearing impairment.
- Contraindications: Hypersensitivity, fever, pregnancy, breastfeeding, skin conditions, concurrent chemotherapy.
- Drug Interactions: None reported.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: See detailed dosage section above.
- Monitoring Parameters: Monitor injection site, vital signs, and symptoms of infection.
Popular Combinations
- Paclitaxel and Cisplatin (in NSCLC)
- Multi-drug therapy (MDT) in leprosy
Precautions
- Administer strictly intradermally.
- Ensure appropriate training for administration.
- Monitor injection site for reactions.
- Screen for contraindications.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Mycobacterium w?
A: Dosage depends on the indication. See the detailed dosage section for specific recommendations.
Q2: What is the route of administration for Mycobacterium w?
A: Strictly intradermal. Intravenous administration has been studied in limited settings.
Q3: Can Mycobacterium w be used in pregnant or breastfeeding women?
A: No, it’s contraindicated.
Q4: What are the common side effects of Mycobacterium w?
A: Injection site reactions (erythema, induration, ulceration), nausea, vomiting, diarrhea, pain, and weakness.
Q5: What are the contraindications for using Mycobacterium w?
A: Hypersensitivity, fever, pregnancy, breastfeeding, generalized skin infections, and certain comorbid conditions.
Q6: Are there any known drug interactions with Mycobacterium w?
A: No significant drug interactions are known.
Q7: How does Mycobacterium w work?
A: It acts as an immunomodulator, primarily through TLR-2 agonism, boosting the body’s immune response.
Q8: Can Mycobacterium w be used in children?
A: Pediatric dosing recommendations aren’t clearly defined in the available literature. Consult with a pediatric infectious diseases specialist for further guidance.
Q9: What precautions should be taken while administering Mycobacterium w?
A: Ensure strict intradermal administration by a trained healthcare professional. Monitor for injection site reactions. Pre-screen patients for contraindications.
Q10: Is there any specific monitoring required during Mycobacterium w therapy?
A: Yes. It is important to monitor the patient for injection site reactions, vital signs and signs and symptoms of infection.
