Omacetaxine (Subcutaneous)

An antineoplastic or cancer medicine, the omacetaxine injection is mainly used in patients who have already received various medicine for chronic myeloid leukemia (CML) and who seem resistant to other cancer medication/therapy.

Overview

Omacetaxine works by interfering with the normal growth of the leukemic cells which then get destroyed by the body eventually. Since Omacetaxine works by destroying body cells, you can expect some side effects with the drug's usage. It's advisable that a patient talks to the doctor before commencing the drug's usage. This will allow the doctor to run some tests and advice accordingly. It is imperative that the drug is administered under the direct supervision of a physician.

Synribo is intended to be used for patients whose cancer has adversely progressed after treatment. If the treatment has progressed with two or more tyrosine kinase inhibitors, then the drug is recommended for the patients. Subcutaneous omacetaxine is a reversible with a transient protein elongation inhibitor factor that facilitates the destruction of deadly tumor cells without depending on BCR-ABL.

While the treatment of chronic myeloid leukemia has been advanced with the availability of TKIs (tyrosine kinase inhibitors), there are many instances where patients are not able to respond to the various TKIs therapies. This could be due to resistance, suboptimal response, intolerance, and disease progression. In this case, Omacetaxine is the most favorable route of treatment for such patients.

What's more, the drug is FDA approved hence giving new hope to leukemia patients who haven't been successful with other drugs. According to the oncology products director, Synribo is the second FDA approved drug for the treatment of CML.

Conditions Treated

  • Chronic myeloid leukemia

Type Of Medicine

  • Antineoplastic or cancer medicine

Side Effects

Like many other drugs that work by destroying body cells, Synribo contains a variety of side effects to look out for. One thing that many cancer drugs share in common is the tendency to pose severe side effects and this medication is not an exception. The most common side effect which you will notice with many cancer treatment drugs is temporary hair loss where normal hair growth comes back sometime after the treatment is complete.

The majority of people using this drug have complained of experiencing serious side effects. In many, if not all instances, it is advisable that you let your physician know if you start experiencing side effects like swollen hands, feet, ankles, joints and back pain etc. While there are many side effects of the drug usage, physicians recommend the drug because it has more benefits to the patient than the side effects. However, careful monitoring by the doctor is advised.

Some of the most common serious side effects of the drug include:

  • Diarrhea, nausea and vomiting
  • Constipation and abdominal pain
  • General body weakness
  • Headache coupled with difficulty sleeping
  • Nosebleed
  • Tiredness
  • Loss of appetite
  • Temporary hair loss which stops when the medication is completed

Also, the patient may experience pain at the injection site but not all the time. You are advised to consult your physician or the nearest pharmacist immediately if the side effects worsen.

Omacetaxine medication results in a decrease in normal bone marrow function which could lead to lower white blood cells, red blood cells and platelets production. This can, in turn, cause anemia which will result in your body losing its power to fight off infections or make existing infections even worse. Lack of platelets leaves your body vulnerable to bleeding out due to lack of the coagulating factor that helps your body form clots to stop bleeding. This could make normally harmless cuts or bruises fatal.

It is advisable that you let your doctor know in case you develop some of the following signs and symptoms.

  • Unusual tiredness which is usually followed or characterized by rapid breathing
  • Easy bruising/bleeding
  • A persistent sore throat, cough, fever, and chills (they could signal an infection building up).

Although rarely, the drug may cause serious but rarely fatal brain bleeding or bleeding in the stomach and in some instances the intestines. Supposing you notice one or two of these following symptoms during the medication you should promptly see a physician:

  • Black stool
  • Persistent stomach or abdominal pains
  • Vomit that seemingly appears to resemble coffee grounds
  • Dizziness/fainting
  • Sudden vision changes and confusion
  • Slurred speech.

While this medication will rarely elevate blood sugar, it can sometimes cause a rise, which could cause diabetes or worsen it. You need to alert your doctor or pharmacist immediately in case you experience any signs of elevated blood sugar like persistent thirst or urination. In case you already are diabetic, you need to regularly monitor your blood sugar and ensure to share your results with your physician. This would make it easy for your doctor to recommend an adjustment of your diet to fight the effects.

In other instances, the drug may cause mild rashes which are not usually diagnosed as serious. However, you need to let your doctor know when you develop a rash. This is because you might not be able to tell the mild rash from a severe rash which could be a sign of a serious condition.

There are some side effects of the medication that occur but usually go away on their own. These side effects do not necessarily need medical attention since they are not considered serious. Your healthcare provider may not be in a position to guide you on how to avoid the side effects or prevent them.

Although also rare, the drug may cause an allergic reaction. Some of the signs of an allergic reaction to look out for include a rash, swollen tongue, face, and throat and severe dizziness and trouble breathing. It's imperative to note that the above list is not the full list of side effects, you need to talk to your physician when you notice anything unusual with your body during the medication.

You should call your physician in case you experience the above side effects. Also, you could contact FDA to report any side effects.

Dosage

Omacetaxine drug comes in powder form which is then diluted and injected into the body. Before you use the drug, you should read the guide and instructions leaflet in the package as advised by your pharmacist to guide you on various dosages. You should read the new instructions on the package every time you get a refill of the drug, where you get a chance to ask any questions you may have concerning the dosage.

Omacetaxine is usually injected under the skin as directed by the doctor and taken twice a day (i.e in a duration of 12 hours) for one to two weeks. The cycle is supposed to be repeated every 28 days also as directed by the doctor. The medication is usually injected in the thigh, but could also be injected in the back of the arm when someone else is doing the administration.

Usually, the dosage depends on an individual's medical condition, laboratory test, body size and their response to treatment. Do not feel the need to increase the dosage if not advised by your doctor. That will not make your condition improve any faster, instead, it could lead to serious side effects as a result of an overdose.

For at-home dosage, you need to consult your physician on how to properly prepare the solution. The leaflet in the package could also provide invaluable information on how to prepare the dosage. It's here that you learn the various ways to prepare, store, transport and discard the medication safely.

It is important to wash your hands or wear clean gloves and protective eyewear when you are preparing the dosage. Before mixing the medicine to inject it, you should look out for signs of discoloration or particles in the solution. If you see any of these signs then do not use it.

You should wash the injection site on your body with alcohol before administering the dose. Change the site next time you inject yourself to lessen instances of injury. Also, do not administer the drug on bruised or scarred body parts. You should also avoid using tender parts like stretch marks as injection sites.

In case the medicine touches your skin or eyes, wash the part and flush your eyes immediately. Use soap and water to get effective results. Call your physician immediately for further guidance.

The recommended dosage for an adult is 3.5 mg for chronic myeloid leukemia. You should use 1.25 mg/m² of SC BID for the first 14 days of the induction into the medication. You should then repeat the dosage for the next 28 days until you achieve a hematologic response.

For maintenance, use 1.25 mg SC BID consecutively for 7 days then 28 days for as long as the clinical benefits of the drug last. You could also modify the dosage to manage various side effects, but this is only advisable under the instructions of your physician.

Dosages could be delayed or the number between the cycles reduced depending on the body's reaction to hematologic toxicity. Nonetheless, you need to follow the guidance of the doctor in this.

Major drug interactions

There are a total of 535 drugs that have interactions with omacetaxine. 159 major interactions and 376 moderate interactions.

Drug interaction for omacetaxine may change depending on how your medication works and the side effects it produces. You should keep a record of every drug you take alongside the medication and share the details with your physician. Normally, you may feel like you should change the drugs you are taking because they result in adverse side effects when combined with Omacetaxine. However, do not stop or modify your medication without the approval or permission from your care provider.

Some of the products that interact with Omacetaxine may in some instances cause bleeding or bruising which includes antiplatelet drugs like clopidogrel. Other drugs that may cause adverse side effects when used alongside omacetaxine include ibuprofen and blood thinners like as warfarin or dabigatran.

Aspirin can also increase the risk of bleeding when paired with this medication. However, suppose your doctor directs that you to inject a moderate to low-dose of aspirin for either a heart attack and possible stroke prevention (this is normally set in dosages of 80-320 mg every day), ensure you continue taking the medication until your doctor advises you otherwise. Also, you should consult your physician/pharmacist for further details. Some of the major drug interactions with omacetaxine include:

  • Alunbrig (brigatinib)
  • Alvesco (ciclesonide)
  • Amaryl (glimepiride)
  • Amen (medroxyprogesterone)
  • Amevive (alefacept)
  • Amjevita (adalimumab)
  • Basiliximab
  • Baycadron (dexamethasone)
  • Bayer AM (aspirin or caffeine)
  • Bayer Aspirin (aspirin)
  • Bayer Aspirin Extra Strength Plus (aspirin)
  • Bayer Aspirin Regimen (aspirin)
  • Cabazitaxel
  • Cabometyx (cabozantinib)
  • Cabozantinib
  • Caldolor (ibuprofen)
  • Calquence (acalabrutinib)
  • Cambia (diclofenac)
  • Insulin
  • Insulin aspart
  • Insulin aspart protamine
  • Insulin aspart / insulin aspart protamine
  • Insulin aspart / insulin degludec
  • Insulin degludec

Warnings

Just like many other drugs, you need to let your doctor know about any allergies you have towards any of the content in the drug before using omacetaxine. This drug may contain some inactive ingredients that can cause an allergic reaction(s) or other underlying problems. You should immediately talk to your pharmacist before you start using the drug for more details.

Prior to using Omacetaxine medication, you should ensure you tell your physician or pharmacist about your medical history. This applies mostly if you have had a history of diabetes and bleeding problems. Also, it is imperative to let your doctor know if you have any current or recent infections.

Generally, Omacetaxine has the potential to make you vulnerable or likely to contract infections or in other instances may worsen current infections. It is therefore advisable that you clean your hands. This is to prevent any potential illness that could result from exposure to germs. With the body weakening effects of the drug, you need to be extra vigilant with illness-causing germs to prevent the spread of infections.

You should also avoid direct body contact with persons with infectious or highly communicable illnesses like chicken pox, flu and measles. For any uncertainty, you should consult your healthcare provider in case you have or suspect you have been exposed to any infection.

Another important precaution you need to keep in mind is not to take part in any immunizations or vaccinations without prior consent from your doctor. Also, you should try and avoid any contact with persons that have received any vaccinations for illnesses such as flu. It is especially important to avoid them if the vaccine was inhaled.

Remember that the drug affects the coagulating factor in your blood so stay away from sharp objects that could cut you. You should not engage in extreme sports that could expose you to risks of bruises.

While this drug may make you tired, using drugs like marijuana and alcohol will make you more tired so you should avoid them. You should limit the use of alcoholic beverages. If you are currently using any form of medical marijuana, let your doctor know prior the drug's usage.

Lastly, if you have to go for surgery, tell your physician or dentist all about the medication and any other drugs you are currently using. This includes prescription drugs, herbal products and non-prescription drugs.

Storage

While this medicine is mostly given in hospitals where the doctor will tell you how to store the drug, sometimes the doctor may advise you to get the drug at the drug store. If you are storing the drug at home, you need to know how to store it safely to avoid instances where the drug goes bad. In such an instance, the drug may become lethal or poisonous.

You should be sure about how long to store Omacetaxine in a refrigerator or at room temperature. You should keep the drug in a safe place away from children or pets. Also, you should check with the pharmacist concerning how to dispose of leftover medicine.

Normally, the advised storage/usage conditions for Synribo should be:

  • Room temperature: you should use the drug within the 12 hours of preparation or reconstitution.

Summary

There are many drugs used in the treatment of chronic myeloid leukemia, but Omacetaxine beats the resistance that many patients display towards other cancer therapies. Apart from being highly effective, the drug can take a toll on the user especially older adults who may be sensitive to the side effects of the drug. The drug mostly affects older adults when it comes to bruises and cuts. This is because apart from old age compromising the body's cells, the drug further weakens the body and makes it vulnerable to platelet destruction effects which may prevent the body from forming clots after cuts. Other problems that may face older adults using the drug include fever, chills and coughs.

It's also important to note that the drug may present complications if administered during pregnancy. To prevent this, the patient should discuss with the doctor about the viability of various reliable birth control methods. If you suspect you are pregnant, you should notify your doctor immediately.

Remember, to get the best out of the drug you need to follow all the instructions given to you and if you suspect any complications ensure you consult your doctor.