Doxorubicin Hydrochloride Injection: The Complete FAQ Guide In 2025

1.Do you know about doxorubicin hydrochloride injection?

Doxorubicin Hydrochloride Injection

Doxorubicin hydrochloride injection is basically a cytotoxic anthracycline antibiotic. For your understanding, let me explain it more precisely that cytotoxic can be a drug that acts upon cell and kills it. Anthracycline is considered as a class of antibiotics that comes from Streptomyces bacteria and it is very potent that it can attack the DNA of cancer cell and makes them die.

You may find this drug most commanding in the treatment of certain cancers like breast cancer, bone cancer, blood cancer, ovarian cancer etc. and that is the reason you consider it a requisite part of cancer chemotherapy alone or with some other drug.

2.How does doxorubicin hydrochloride injection work?

Do You Know How Does Doxorubicin Hydrochloride Injection Work?

The second thought that may hit your mind that how is this anti-tumor drug working so well? So learning the way it affects the tumor cells is very easy. A key enzyme known as topoisomerase 2, contributes in replication of DNA. These enzymes form a bond with DNA which you can say topoisomerase 2-DNA complex.

When you administer doxorubicin hydrochloride injection, it strengthens the bond between topoisomerase 2 and the DNA, by which you get the result of separation of DNA strands and in the end replication of DNA stops, bringing tumor cells to death.

3.What kinds of cancer can be treated by doxorubicin hydrochloride injection?

As you got to know that doxorubicin hydrochloride injection exerts its cytotoxic ability to deal with many kinds of cancer. The question arises what are these kinds of cancer? So here is the list for you:

Sarcoma:

Sarcoma-Picture Courtesy: Oncoplus

Sarcoma, you can describe this kind of cancer as cancer of bones and soft tissues. When you search about it, you got to know that this cancer can be initiated from nerve, muscles, tendons, joints, vessels etc. as all of them are regarded as soft tissues. Such lethal cancer can be treated by doxorubicin hydrochloride injection.

Leukemia:

Leukemia-Picture Courtesy: Mount Elizabeth Hospitals

Do you sense what leukemia means? In simple words, it is cancer of blood. And if you mean it in broader way, it is the cancer of blood and bone marrow together. Basically bone marrow lacks to produce normal white blood cells and immunity gets down in response. There remains no one to combat with infection that is invading the body.

Then can you figure out what happens? Bone marrow stops forming red blood cells and platelets. Such hard condition is managed by administering doxorubicin hydrochloride injection.

Lymphoma:

Lymphoma-Picture Courtesy: Lymphoma Challenge

Are you informed about the importance of lymphatic system? It counts as an integral part of your immune system and fights for your body with bacteria, virus etc. Cancer of such an important system is denoted as lymphoma. You can administer doxorubicin hydrochloride injection to act against lymphoma.

Breast carcinoma:

Breast Carcinoma-Picture Courtesy: Daily Nation

Have you heard about breast carcinoma? As you may know that un-usual multiplying of cells creates a tumor that is the fundamental way of initializing breast carcinoma. Doxorubicin hydrochloride injection takes part to stop that unwanted multiplication and tumor cells get died by the process of apoptosis.

Lung cancer:

Lung Cancer-Picture Courtesy: Drugwatch.com

You can get the idea about this cancer through its name. Actually, there is growth of tumor in tissues of lung and condition worsens after this. To treat such tumor, doxorubicin injection is injected according to suitable dose.

Other Cancers:

Doxorubicin Hydrochloride Injection Used In Ovarian Cancer

In addition to the above cancers, there are some other types of cancer that you need to know about. Doxorubicin is dominantly used to treat gastric cancer, bladder cancer, kidneys cancer, ovarian cancer and thyroid cancer. It is good for you to have thorough knowledge of uses of this anti-tumor injection, so that you can spread right information to others.

4.What is the suitable dose of doxorubicin hydrochloride injection? And how it can be administered?

Dose of doxorubicin hydrochloride injection:

Dose Of Doxorubicin Hydrochloride Injection

When it comes to gaining the prominent effects of any medicine, you need to administer it in suitable doses. Now here it is essential for you to know that this injection can be administered as a single drug or with any other drug to suppress the cancerous cells.

Dose as single drug:  You can observe that when it is given alone to treat a cancer, it is administered in doses of 60 mg/m2 to 75mg/m2, this range is considered as effective to fight against tumor cells. This dose is given every day and treatment extends to 21 days.

Dose as an adjuvant: This is understandable for you that any drug can be given in combination to manage a disease condition. But when you administer a drug with other one, you reduce some of its dose so that you will receive remarkable effects with fewer side effects. Range described for adjuvant therapy is 40mg/m2 to 75mg/m2, which is administered daily and this therapy prolongs for 21-28 days as per requirement.

One more thing which you have to be aware is that dose can be altered if the patient is suffering from obesity or old aged.

Administration of doxorubicin hydrochloride injection:

How Doxorubicin Hydrochloride Injection Administers-Picture Courtesy: Science

You learnt in the beginning that doxorubicin hydrochloride injection only can be given through intravenous route to attain good effects, but why?  You could experience tissue damage when this injection is given by skin or muscle. Now here you will receive details about its administration protocols. It is introduced in the body by intravenous bolus and given into vein that has large size to avoid any trouble.

You can search about its infusion rate and you come to know that it must be given in more than five minutes. Fast administration is not favorable as it can cause other problems like flushing of face, accumulation of substances & fluids around vein or even inflammation of lymphatic vessels. You need to follow proper instructions for administration of doxorubicin hydrochloride injection.

5.What are the conditions that do not favor the administration of doxorubicin hydrochloride injection?

You are well informed by the advantageous role of doxorubicin hydrochloride injection but there are some conditions that do not support its administration in the body. You need to know this in order to spread correct information regarding its use.

Serious myocardial inadequacy:

Serious Myocardial Insufficiency-Picture Courtesy: Sakra World Hospital

Do you know what myocardial inadequacy is? Myocardium is the muscle layer of heart, and this helps the heart to perform its primary function which is pumping of blood to other organs of body.

Problem arises in ability of these muscles of heart that they face difficulty in supplying enough blood and you called such condition as serious myocardial inadequacy. Doxorubicin hydrochloride injection is not recommended in this disease condition as it worsens upon anti-tumor drug administration.

Myocardial infarction:

Heart Attack-Picture Courtesy: Carda Health

Are you familiar with word heart attack? It is another name of myocardial infarction. As you have this understanding that heart is in serious compromised state that it fails to do basic function. Recent occurrence of myocardial infarction puts a restriction on use of doxorubicin hydrochloride injection as this drug makes heart more vulnerable.

Myelosuppression:

How Bone Marrow Looks Like-Picture Courtesy: ProHealth Clinic

Do you have any idea about myelosuppression? It is a disease condition in which blood cells formation gets down in bone marrow. Doxorubicin hydrochloride injection is among those drugs that can exaggerate this disease to many folds and that’s the reason it is not used in myelosuppression. Serious consequences can lead to drug induced leukemia.

Liver impairment:

Liver Impairment-Picture Courtesy: Metropolis Healthcare

Do you know that which route is utilized to eliminate doxorubicin hydrochloride from body? It’s hepatic route and that is the reason it is not allowed to administer this anti-cancer drug when your liver is not functioning properly.

Serious hypersensitive reactions:

Anaphylactic Shock-Picture Courtesy: Cottonique

You must be informed that doxorubicin hydrochloride injection itself can be the reason of hypersensitive reactions. It is prohibited to administer this cytotoxic drug  when someone is having such reactions, as it makes this situation more severe that it can be resulted in anaphylactic shock which is life threatening.

Pregnancy:

You know it well that pregnancy is not a disease condition that can be triggered by administration of cytotoxic drug but it is a state in which woman is carrying fetus and wellbeing of fetus is top priority. Doxorubicin hydrochloride injection cannot be given to pregnant ladies as it can cause severe damage to growing fetus.

6.Do you know the undesirable effects caused by doxorubicin hydrochloride injection?

Doxorubicin hydrochloride injection shows up with different undesirable effects. Have you pondered why this happens? The reason behind it is very simple, this drug is cytotoxic and it works by attacking cells, which in return also affect the immunity of body and many unwanted effects have been experienced by patient. Here you find the list of some common side effects of this anti-tumor drug.

Undesirable effects	Image
Cardiotoxicity	Picture Courtesy: IMR Press
Loss of hairs	Picture Courtesy: Yale Medicine
Nausea, vomiting and diarrhea	Picture Courtesy: Apollo Hospitals
Puffed hands and feet	Picture Courtesy: Emirates Hospital
Trouble breathing	Picture Courtesy: Metropolitan Cardiovascular Consultants, LLC
Fatigue	Picture Courtesy: Harvard Health
Loss of appetite	Picture Courtesy: Verywell Health
Reduce blood count	Picture Courtesy: Healthy Directions

7.What are the ingredients used to make doxorubicin hydrochloride injection?

Doxorubicin hydrochloride injection requires some important ingredient to manifest its strong effects. Here you can get description of why these ingredients are used in making of this drug.

Ingredients:	Why it is used?
Doxorubicin	It is denoted as the main ingredient and you can say it “active pharmaceutical ingredient (API)” The drug is showing anti-tumor activity because of this ingredient. Other ingredients are denoted as inactive and they support the action of active ingredient.
Sterile water for injection Picture Courtesy: Wikipedia	This ingredient holds so much importance and do you know why? It acts as carrier, used to make solution of drug and facilitates the transfer of drug into body.
Sodium chloride	Do you k now who is managing the isotonicity of this formulation? It is sodium chloride.
Hydrochloric acid	This ingredient is added to maintain the pH of formulation.

Are you wondering that there is no preservative? Yes, it is made sure to never include preservative in this formulation and reason is to avoid any incidence of toxicity.

8.Do you have any idea in which form and dispensing container doxorubicin hydrochloride injection is available in the market?

Forms of doxorubicin hydrochloride injection available in market:

When you observe about available forms of doxorubicin hydrochloride injection, you can find that this formulation is available in both forms like in lyophilized powder and in red clear solution. Why is it so? You will get your answer in this topic precisely.

Lyophilized powder:

Lyophilized Powder Of Doxorubicin Hydrochloride Injection

First you learn that why is it available in lyophilized form? This formulation does not contain any preservative and upon testing its stability it is revealed that it is least stable during shelf life.

To keep it stable, it is changed in lyophilized form and by this you can get privileges like it can be stored in little refrigeration facility as it is heat stable, it remains stable for longer time during shelf life and it can be reconstituted when needed with suitable diluent.

Red sterile solution:

Red Sterile Solution Of Doxorubicin Hydrochloride Injection

You can see the red sterile solution is marketed as doxorubicin hydrochloride injection, although it is understood that this formulation has shorter stability during shelf life and demands strict availability of cold-chain for storage.

So the reasons of dispensing sterile solution are to provide formulation that contains precise amount of every ingredient, save time for its making and minimize any kind of expected errors during preparation.

Dispensing container:

Glass Vial Is Used To Dispense Doxorubicin Hydrochloride Injection

Do you pay attention that mostly sterile solutions for injection are dispensed in vials? Same goes for this anti-tumor drug, doxorubicin hydrochloride injection is marketed in glass vials and you will get the reason why?

It is packaged in amber-glass vial or transparent glass vial to save formulation from degradation caused by light exposure. Keep in mind that doxorubicin is light-sensitive ingredient. Plastic vial is avoided as it can have reaction with components of product.

Single-dose vial is used because it does not contain preservative and lacks the ability to remain stable for so long.

It is closed with tamper-proof seals to get the idea about damage.

9.What can be the process of making doxorubicin hydrochloride injection?

You are well aware that the doxorubicin hydrochloride injection comes under the pharmaceutical sterile formulations and that’s the reason it demands a proper protocol for its making. The production area is made aseptic and controlled environment is established to prevent any possible source of contamination.

Procurement & measurements of ingredients:

Procurement & Measurement Of Ingredients

Have you perceived the importance of correct procurement and measurement of ingredients? This step is initial one and should be carried out with proper care. Ingredients must be taken from authentic sources and suppliers should hold reliable certification for keeping such valued ingredients.

Sterile water for injection is obtained by using water treatment system and this system must be assessed properly that it is delivering the water of same purity that is demanded by the formulation.

Now if you want profound effects of a drug, you need to add accurate amount of ingredients. For this purpose, you can use analytical balances which are very common in pharmaceutical industry to weigh the APIs and excipients.

Forming a sterile solution:

Forming a sterile solution in clean room

Preparation of sterile solution is made possible in clean room, keeping environment controlled. Can you comprehend which equipment is suitable to form a sterile solution? It is pharmaceutical mixing vessel, which is used extensively in production of pharmaceutical products.

Sterile solution is prepared by initially mixing doxorubicin with sterile water for injection, and then includes sodium chloride and hydrochloride in it to form a red clear solution for injection.

Sterile filtration:

Sterile Filtration

Have you sensed that preparation is made sterile as it is introduced directly into the body, and to ensure sterility you can use sterile filter. This filter is applicable to remove harmful substances either unwanted particles, pyrogens or endotoxins. Process is known as sterile filtration and carried out before filling of formulation in vials.

Filling and sealing of vials:

Filling & Sealing Of Vials-Picture Courtesy: Lighthouse Worldwide Solutions

You have read it before that doxorubicin hydrochloride injection is filled in glass vials but the process behind its filling and sealing must also be known by you. Aseptic filling lines are chosen to fill and seal formulation and equipment is selected on the basis of kind of product you want to dispense in vials, like vial filling line for liquids or lyophilized powder.

Process starts with washing of vial at washing station then vial is sent for sterilization, which is done by heat or UV light. Sterile vial is shifted to filling station and filled accurately by the help of filling nozzles. After filling, vial gets sealed with rubber stopper crimped with aluminum cap.

Do you know what is done to change the sterile solution in to powder? Process of lyophilization is practiced, in which sterile solution is freeze-dried to remove water content from it. Vials containing formulation are subjected for freeze drying in lyophilizer. After lyophilization, vials are sent for inspection.

Inspection system is installed to detect any defects in vial or formulation present in the vial.

Lyophilization-Picture Courtesy: Groupe Berkem  

Final sterilization:

Final Sterilization

There is always requirement left for final sterilization and do know why? Formulation may allow inclusion of some contaminants during filling and sealing, so to eliminate these contaminants; you can use autoclaves for final sterilization.

Quality control:

Quality Control-Picture Courtesy: ATLEN Portugal

You are going to market a drug, which serves as first line of chemotherapy, don’t you feel need to test it for once? Yes it is requisite to perform different tests to inspect sterility, stability, pH, purity of API, microbial presence etc. in this way you will be sure about high quality of your sterile product.

Labeling and packaging:

Doxorubicin Hydrochloride Injection Labeled Vial And Packaging Box

Have you spotted some packaged vials of doxorubicin hydrochloride injection? These are labeled with some essential information like active ingredient, quantity & form of API, route of administration, batch number; expiry date etc. and these labels are applied in printed form by labeling machines. Boxes are used to pack this sterile product by using cartoning machine.

10.What are the key machines used in formation of doxorubicin hydrochloride injection?

After getting acknowledged with the whole process of manufacturing, have you realized the necessity of well-functioned equipment for each step? Yes, it is utmost demand to use efficient machines that can meet regulatory standards.

Key machines	Image
Analytical balance: This balance is used in pharmaceutical industries to measure the accurate weight of ingredients, intended to use in formulation manufacturing.
Water treatment system: Water treatment system  is integral part of sterile production as it takes part in providing the highly pure and sterile water for injection.	Aipak Water Treatment System
Pharmaceutical mixing vessel: This mixing vessel is responsible to perform an important step of mixing the ingredients uniformly. It is equipped with temperature control system and agitator .
Sterile filter: Sterile filter utilizes the porous membrane to separate undesirable particles, endotoxins, pyrogens from sterile solution. It is used to filter the solution after it has passed the step of mixing.
Vial filling line for liquids: Vial filling line is well equipped and fully automated machine. It takes part in proper filling and sealing of vial. It is comprised of: Washing machine Sterilization machine Filling and sealing machine RABS (restricted access barrier system) is used to protect the whole operation from getting contaminated.	Aipak Vial Filling Line For Liquids
Vial filling line for lyophilized powders: Vial filling line for lyophilized powder works same as above. Only one difference is present. It is connected with lyophilizer. After being filled & sealed, vial is moved to lyophilizer, which converts solution into freeze dried powder.	Aipak Vial Filling For Lyophilized Powder
Lyophilizer: Lyophilizer is specially designed equipment, functions to change the solution state of formulation into powder state and do you know why? In order to keep the formulation stable. Process follows by lyophilizer is so simple. Initially formulation is frozen then pressure & temperature are made decreased to the level that frozen water changes into gaseous form. In this way water is eliminated and in the end you receive powder form which remains stable for longer time.	Picture Courtesy: Dara-Lyo
Autoclave: Autoclave is the fundamental instrument used for final sterilization of product. Steam is utilized to kill possible microbes present in formulation.
Labeling machine: Vials are labeled by the help of labeling machines. Labels are printed with important information then applied on vials by self-adhesive or pressure techniques.
Cartoning machine: Vials are packed in boxes by using cartoning machine. Packaging must be accurate to avoid trouble during storage and transportation. For this purpose, it is necessary to use efficient equipment.	Aipak Cartoning Machine

11.What is the storage protocol required by doxorubicin hydrochloride injection?

Storage Protocols For Doxorubicin Hydrochloride Injection

Do you have idea that which thing helps you to keep drug stable during shelf life? It is the awareness of storage protocol that can save formulation from degradation. Doxorubicin hydrochloride injection can be stored for two years after being manufactured but few things need to be maintained during storage.

Temperature is very important factor and high temperature can degrade your formulation. This important anti-cancer drug is stored in refrigerator by keeping temperature 2-8℃.

Excessive light exposure can make the formulation less potent, so avoid light exposure especially UV light.

Make sure vial is not damaged or leaked as it can cause expiration of drug before ending of shelf life.

12.Are you aware of interactions of doxorubicin hydrochloride injection with other drugs and food?

You have witnessed the effective role of doxorubicin hydrochloride injection but its effects can be altered in presence of some food or drug. Realization of such information is crucial for you in order to avoid interruption in flawless treatment by this anti-tumor drug.

Food interactions:

You must avoid following food while being treated by doxorubicin hydrochloride injection.

Food interactions:	Image:
Grape fruit: This fruit must not be taken as it induces the effects of doxorubicin by inhibiting its metabolism and increasing concentration in serum.
St John’s wart: A well-known herb but not good for the one, who is receiving treatment by doxorubicin hydrochloride injection. It elevates its metabolism and minimizes the serum levels, which results in low effects of this drug.
Curcumin: This ingredient and food containing it, is not favored to be consumed when you get administered with doxorubicin hydrochloride injection. Effectiveness of this drug becomes low.

Drug interactions:

Drug Interactions Of Doxorubicin Hydrochloride Injection

Drug interactions are very common with doxorubicin hydrochloride injection and you must be well-informed with it.

All the drugs that could be anticonvulsants, antibiotics etc. and  have capability to increase the enzymes CYP3A4, CYP2D6 and p-glycoprotein are not encouraged to be taken with this drug. Reason is that these drugs can minimize the effects of doxorubicin.

Any drug like clarithromycin, ketoconazole, verapamil etc. that possesses the ability to suppress the CYP3A4, CYP2D6 and p-glycoprotein, must not be used along with doxorubicin. It can elevate the doxorubicin effects.

Paclitaxel is anti-cancer drug but it should not be used before administration of doxorubicin hydrochloride. In return, it can increase its serum concentration which can lead to toxicity.

Monoclonal antibody Trastuzumab, a well-known anti-tumor drug but its use with doxorubicin is toxic. You can observe severe cardiac toxicity when they both are administered together.

Dexrazoxane, which is used to protect heart from getting damaged but does not work with doxorubicin hydrochloride injection. Their combined administration causes the decrease in response of tumor.

Mercaptopurine, a popular anti-cancer drug, used in leukemia but its administration with doxorubicin hydrochloride can be resulted in severe liver toxicity.

13.Can you illustrate about precautions that must be practiced for using doxorubicin hydrochloride injection?

Precautions You Need To Take While Using Doxorubicin Hydrochloride Injection

You have discovered about usefulness, adverse effects, contraindications and interactions of doxorubicin hydrochloride injection. After knowing all of these things, do you feel the need of strict following of precautions for using such potent drug? Here you can get awareness about precautions that are necessary to be practiced.

First thing, which is important is to check the expiry, vial condition and formulation appearance before administering. Injection must be given by oncologist or well-trained staff. Use of chemical resistant gloves, mask, lab coat and shoe covering should be made possible. Pregnant ladies must not be chosen to administer the drug.

You must be careful about infusion rate. It is recommended to give in slow rates otherwise accumulation of drug can be occurred around vein.

You must be aware of patient’s cardiac condition, blood count, allergies, liver function before administering drug.

You must be well-informed with contraindications, interactions and side effects of doxorubicin hydrochloride injection. Any incidence of side effect must be treated on time.

You must avoid interaction with people suffering from any infection as there is possibility to be harmed by infection. Immune system gets compromised after using doxorubicin hydrochloride injection.

You must not give this drug to pregnant and breastfeeding ladies as it can affect the fetus health or can be excreted in breastmilk.

Conclusion:

Doxorubicin hydrochloride injection serves as a potent anti-tumor drug to fight with many cancers effectively. Learning about the side effects, contraindications and interactions is as requisite as being aware of its uses. Manufacturing of this anti-tumor drug requires high quality ingredients, well equipped machines and compliance to mandatory standards. Do you want more awareness about doxorubicin hydrochloride injection? AIPAK Engineering presents complete knowledge about this cytotoxic drug. If you have any question in your mind, you can feel free to contact us anytime!