Emergency Gynecologic Methotrexate Kit


The Emergency Gynecologic Methotrexate injection (mtx injection) from Edge Pharma solves a major issue affecting hospitals and OB/GYN clinics. In facilities without a USP 800 compliant hazardous cleanroom, preparation and administration of Methotrexate is a challenge. With the EmGyn Emergency Gynecologic Methotrexate Kit, any hospital or clinic can now confidently administer adjustable patient-specific body surface area based doses of Methotrexate up to 125mg. As an FDA-Registered 503B Outsourcing Facility we are able to dispense EmGyn Kits without requiring patient names.

Emergency Gynecologic Methotrexate Kit comes prefilled with 5mL of Methotrexate 25 mg/mL in an administration syringe. The administration syringe is connected to a waste syringe through a closed system transfer device (CSTD). Body surface area based dosage is achieved by activating the CSTD, transferring the unneeded Methotrexate into the waste syringe, deactivating the CSTD, and then detaching the waste syringe from the system. The waste syringe can then be safely disposed of in an appropriate hazardous waste container, while the administration syringe now contains the desired amount of Methotrexate. Hence any dose up to 125mg can be selected and easily prepared for administration.

 
EmGYN kit m2

 

EmGyn Kit Features 

  • The simplest solution for Emergency Methotrexate to help comply with USP 800.
  • 125mg/5mL Methotrexate. Enables body surface area based dosing.
  • Ability to prepare any dosage up to 125mg without the need for hazardous cleanroom facilities. No compounding required.
  • Dispensed without Patient Names.
  • Includes closed system transfer device.

pdf logo 35EmGyn Kit Documentation (pdf)

 

Literature Review

 

Is preparation of the EmGyn Kit considered compounding?

The FDA defines compounding as “the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.”(1)

  • Does preparation of the EmGyn Kit require combining? NO
  • Does preparation of the EmGyn Kit require mixing? NO
  • Does preparation of the EmGyn Kit require altering ingredients? NO

The USP defines compounding as “The process of combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication.”(2)

  • Does preparation of the EmGyn Kit require combining? NO
  • Does preparation of the EmGyn Kit require admixing? NO
  • Does preparation of the EmGyn Kit require diluting? NO
  • Does preparation of the EmGyn Kit require pooling? NO
  • Does preparation of the EmGyn Kit require reconstituting? NO
  • Does preparation of the EmGyn Kit require repackaging? NO 

- The administrable dose within the EmGyn Kit comes prefilled within the container (i.e. syringe) utilized for administration.  As such, the administrable dose does not require repackaging.

  • Does preparation of the EmGyn Kit require altering? NO

 

By the FDA’s and the USP’s definitions, preparation of the EmGyn Kit does not require compounding.

 


(1) Compounding and the FDA: Questions and Answers [https://www.fda.gov/drugs/human-drug-compounding/]
(2) USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations (Glossary, page 33)

 

USP 800 and Hazardous Drugs 

USP 800 provides standards for safe handling of hazardous drugs (HDs). The Centers for Disease Control reports that 8 million health care workers are potentially exposed to hazardous drugs, which can result in adverse health effects. These workers include pharmacy and nursing personnel, operating room and research lab personnel, and shipping and receiving workers. OSHA recognizes USP 800 standards as the national professional standard to protect the safety and health of employees. Local, state, and federal entities can enforce USP 800.(1)

Methotrexate is a hazardous drug that is classified as an antineoplastic agent. Antineoplastic agents, most often used to treat cancer, are harmful to cancerous cells and also to healthy cells and tissues. According to the CDC, there are both short and long-term effects from exposure to these agents. “These include liver and kidney damage, damage to the bone marrow, damage to the lungs and heart, infertility (temporary and permanent), effects on reproduction and the developing fetus in pregnant women, hearing impairment and cancer.”(2)

According to the American College of Obstetricians and Gynecologists, methotrexate is the most common drug used to treat ectopic pregnancy. “This drug stops cells from growing, which ends the pregnancy. The pregnancy then is absorbed by the body over 4–6 weeks. This does not require the removal of the fallopian tube.”(3)

Facilities that need to provide this life-saving treatment to patients must abide by USP 800 standards in order to protect all healthcare workers who may have contact with methotrexate. Edge Pharma solves this challenge by providing the Emergency Gynecologic Methotrexate Kit prefilled with 125 mg of methotrexate in an administration syringe. No compounding is necessary at the hospital or facility; thus, greatly simplifying USP 800 compliance.


(1) Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, Medical Surveillance for Healthcare Workers Exposed to Hazardous Drugs, https://www.cdc.gov/
(2) Centers for Disease Control and Prevention, Hazardous Drug Exposures in Healthcare, https://www.cdc.gov/
(3) American College of Obstetrics and Gynecologists, Ectopic Pregnancy, https://www.acog.org/

 

Ectopic Pregnancy 

An ectopic pregnancy is when a fertilized egg grows outside the uterus, usually in a fallopian tube.(1) The March of Dimes reports that 1 in 50 pregnancies is ectopic, or “tubal.” Ectopic pregnancy always ends in pregnancy loss.(1) The American College of Obstetricians and Gynecologists lists several risk factors for ectopic pregnancy. They include:

• Previous ectopic pregnancies
• Prior fallopian tube surgery
• Previous pelvic or abdominal surgery
• Certain sexually transmitted diseases
• Pelvic inflammatory disease
• Endometriosis
• Cigarette smoking
• Age older than 35 years(2)

While initially an ectopic pregnancy may seem like a typical pregnancy, particular symptoms indicate the pregnancy may be ectopic. These include abnormal bleeding, low back pain, and cramping on one side of the pelvis. As the pregnancy grows, more serious symptoms may be experienced such as sharp pain and fainting. A ruptured fallopian tube can cause bleeding that is life threatening to the mother.(3)

An ectopic pregnancy is diagnosed by a pelvic exam, an ultrasound and blood tests. An early ectopic pregnancy is most often treated with methotrexate, according to the Mayo Clinic. Methotrexate works by dissolving cells and preventing new cell growth.(4) The pregnancy is absorbed by the body and removal of the fallopian tube is not required.(5)


(1) March of Dimes, online article, Ectopic Pregnancy https://www.marchofdimes.org/
(2) American College of Obstetricians and Gynecologists, online article, FAQ Ectopic Pregnancy https://www.acog.org/
(3) American College of Obstetricians and Gynecologists, online article, FAQ Ectopic Pregnancy https://www.acog.org/
(4) Mayo Clinic, online article, Ectopic Pregnancy: Diagnosis and Treatment https://www.mayoclinic.org/
(5) American College of Obstetricians and Gynecologists, online article,  FAQ Ectopic Pregnancy https://www.acog.org/

 

References 

Cecchino, G.N., Araujo Júnior, E. & Elito Júnior, "Methotrexate for Ectopic Pregnancy: When and How," J. Arch Gynecol Obstet (2014) 290: 417. https://doi.org/

"In spite of new treatment modalities and improvement of diagnostic methods, ectopic pregnancy (EP) is still the leading cause of maternal death in the first trimester of pregnancy, accounting for 6-13% of all pregnancy-related deaths."

"In industrialized countries, up to 2% of all pregnancies are ectopic in location.

"Considering MTX in tubal pregnancy, it proved to be more effective in cases of low titers of beta-hCG and masses with a small diameter, although there is still no uniformity of these parameters. Additionally, non-tubal ectopic pregnancies are associated with greater morbidity and may require medical treatment with direct injection or systemic MTX, which have been used effectively."

 

Register To Order Online  

We are currently licensed to sell to all US states except Alabama and Virginia. Register for an online ordering account to order mtx injection. 

Create an account to order

Log-In if you have an account