Sargramostim (Intravenous)

Manufactured from yeast, Sargramostim, functions as an immunostimulator and helps to produce white blood cells.

Overview

Sagramostim is a man-made protein which helps to simulate the growth of white blood cells in the body. These cells help to fight against infection and can be useful in preventing complications which can arise in conditions such as bone marrow transplant, leukemia or pre-chemotherapy collection of blood cells. This medicine is typically used in adults who are at least 55 years of age.

In addition to the conditions it is approved to treat, Sargramostim has also shown promise in treating gastro-intestinal disorders such as Crohn's disease. It may also be useful in treating oncolytic reovirus associated with brain cancer, and can be prescribed "off-label"at the discretion of a physician for these and other purposes.

This medicine is marketed in the US by Genzyme under the brand named Leukine, as a recombinant granulocyte macrophage colony stimulating factor (GMCSF) which functions as an immunostimulator. It was first identified in 1985, and approved by the FDA in March 1991 for the acceleration of blood cell recovery. By November 2006, it had also been approved for the treatment of fungal infections.

Type of medicine

  • Immunostimulator

Conditions treated

  • Neutropenia
  • Pulmonary alveolar proteinosis
  • Cancer
  • Bone marrow transplant

Side effects

Along with the desired side effects, Sargramostim can also potentially cause unwanted side effects in certain patients. The most common side effects reported by patients undergoing treatment with this medication include the following: abdominal pain, increased hunger, black or tarry stools, bloating or swelling of the extremities, an increase in urination, increased thirst, bloody eyes, irregular heartbeat, bloody nose, blood in stools, blurry vision, aches and pains, bone pain, cloudy urine, chest pain, congestion, decrease in urine, cough, difficulty breathing, drowsiness, dry or sore throat, fast or pounding heartbeat, fever, flushed skin, fruit-like breath odor, fatigue, wheezing, yellow eyes or skin, changes in voice, trembling, unusual weakness or tiredness, swollen neck glands, runny nose, weight gain, nausea, vomiting, mood or mental changes, spasms, seizures, and/or an increase of cholesterol in the blood.

As the patient continues to take this medication as prescribed, many (if not all) of the previously mentioned side effects should lessen. If side effects persist over a prolonged period or appear to get worse, the patient is advised to contact their doctor. Some minor side effects such as a dry throat, dry mouth or increased level of thirst can be alleviated by simply sucking on sugar-free rock candy, chewing sugar-free gum or taking regular drinks of cold water. Other side effects may be alleviated by over the counter remedies or natural treatments.

The majority of patients only experience minimal side effects while undergoing treatment with Sargramostim. Most physicians agree that the benefits of receiving treatment with this medicine vastly outweigh the risks of minor discomfort associated with side effects.

Other side effects experienced rarely, albeit often enough to warrant mentioning, include the following: diarrhea, difficulty moving, difficulty sleeping and/or chills. Patients are advised to check with a healthcare professional if these side effects prove bothersome.

Patients who experience a headache, rash or general feeling of discomfort or illness are advised to get emergency help immediately, as these side effects are symptomatic of overdose.

Because Sargramostim can potentially affect the psychology of the patient, he or she may be at increased risk of experiencing confusion, mood swings, hallucinations or depression. Patients are therefore advised against driving or operating heavy machinery while undergoing treatment with this medication, and great caution should be taken when prescribing Sargramostim to patients with a history of mental health problems such as depression, schizophrenia or bipolar disorder.

Dosage

As with all medications, it is important for patients to be treated with Sargramostim only as prescribed by a qualified doctor. This means that patients should not receive any more of this medicine than advised, either in terms of dose size or frequency. In addition to this, treatment should be discontinued if a doctor advises so, even if a supply of the medicine remains.

Sargramostim is administered intravenously, typically in a clinical setting. Although the manufacturers of this medicine provide general dosage instructions, it should be reiterated that these are merely recommendations and will most likely be altered by the patient's doctor based on a number of criteria, including the height, weight, age and condition of the patient.

Dosage for neutropenia associated with chemotherapy:

Patients diagnosed with neutropenia who are currently undergoing chemotherapy should be administered with 250mcg/m2/day Sargramostim intravenously, over a four-hour period. Treatment should begin on or around day 11, or 4 days after the completion of induction chemotherapy, provided that the patient's bone marrow is hypoplastic with less than 5% blasts on day 10. In cases where a second cycle of chemo is required, Sargramostim should be given approximately 4 days after this cycle on account of bone marrow being hypoplastic with less than 5% blasts. Treatment should continue until absolute neutrophil count is larger than 1500 cells per mm3 for three consecutive days.

Dosage for myeloid reconstruction post-bone marrow transplant:

For myeloid reconstruction, patients should receive 250mcg/m2 per day of Sargramostim intravenously, with treatment beginning 2-4 hours after bone marrow infusion, and at least 24 hours after the last dose of radiotherapy or chemotherapy, when the absolute neutrophil count is less than 500 cells/mm3. Treatment should continue until ANC is larger than 1500 cells/mm3 for three consecutive days.

Dosage for peripheral progenitor cell transplantation:

During mobilization, 250mbc/m2 per day should be administered over a 24-hour period, intravenously. This dose should be continued throughout peripheral blood progenitor cell collection. The same dose should be administered post-transplantation, until absolute neutrophil count is greater than 1500 cells/mm3 for three consecutive days.

Interactions

All drugs have the potential to interact with other chemicals or medicines within the human body, and these interactions can potentially change the effects of one or more of the medications involved. In some instances, medicines can be rendered ineffective by these interactions, and in certain circumstances interactions can cause potentially dangerous or even fatal side effects. Because of this risk, patients are advised to keep a full list of all medications they are currently taking. This extends to complementary medicines, over the counter remedies, herbal supplements and vitamins as well as prescription drugs.

Below is a partial list of drugs known to interact negatively with Sargramostim. Patients who are undergoing treatment with any of the following medicines should inform their doctor prior to receiving a dose of Sargramostim:

  • Abemaciclib
  • Altretamine
  • Arsenic trioxide
  • Azacitidine
  • Belinostat
  • Bleomycin
  • Bexarotene
  • Busulfan
  • Cladribine
  • Cytarabine
  • Dacarbazine
  • Doxorubicin
  • Etoposide
  • Eribulin
  • Fluorouracil
  • Fludarabine
  • Gemcitabine
  • Gemtuzumab
  • Irbrutinib
  • Irinotecan
  • Ixabepilone
  • Lithium
  • Mitocytin
  • Methotrexate
  • Niraparib
  • Osimertinib
  • Pazopanib
  • Ruxolitinib
  • Sprycel
  • Yondelis

Warnings

Patients who are allergic to yeast should not be treated with this medication. This is because Sargramostim is derived from yeast. Patients with allergy will require an alternate treatment.

Prior to treatment, a doctor should perform a series of blood tests in order to ascertain whether the patient suffers from any conditions that could prevent them from safely undergoing treatment with Sargramostim. This medicine should not be used on patients with any of the following:

  • Pleural effusion (a build-up of fluid around the lungs)
  • Cancer of the bone marrow
  • Fluid retention
  • Heart disease
  • High blood pressure
  • Congestive heart failure
  • Epilepsy or any other seizure-causing disorder
  • Kidney disease
  • Liver disease
  • Asthma
  • Chronic obstructive pulmonary disease
  • Sleep apnea

Using Sargramostim can potentially increase the risk of developing certain other cancers. Patients are advised to discuss individual risks with their doctor.

There are no conclusive studies to suggest whether this medication is harmful to unborn babies, although healthcare professionals recommend that it is used only if the benefits of doing so far outweigh any risk factors. Patients who are pregnant or intending on becoming pregnant soon should inform their doctor prior to treatment with this medication.

It is unknown whether Sargramostim is passed into breast milk, or whether it affects nursing babies. However, official FDA guidelines suggest proceeding with caution or stopping breastfeeding for the duration of treatment with this medicine.

Storage

This medicine should only be administered in a clinical environment. A qualified healthcare professional should mix Sargramostim powder with sterilized water prior to injection. After mixing, the medicine must be used within 6 hours, unless it has been mixed with bacteriostatic water, in which case it must be used within 20 hours. Sargramostim should be stored in a refrigerator until it is ready to be used. It must not be frozen.

Summary

Sargramostin is an effective immunostimulator which helps the body to produce white blood cells to be used for fighting infection. It is therefore a useful medicine for those with neutropenia after a bone marrow transplant.

Although it is a greatly beneficial medication, Sagramostin is not without its risks and should only be used as directed by a physician, in a clinical environment such as a hospital. Patient and doctor are advised to work together to ascertain the optimum dosage levels.

Resources
Last Reviewed:
December 24, 2017
Last Updated:
April 05, 2018
Content Source: