Injectafer is a brand-name prescription drug that has been approved by the FDA to treat Iron Deficiency Anemia or IDA in adults. If you are suffering from IDA, you have anemia or a low red blood cell level due to low iron in your body. According to recent research, Injectafer may cause severe hypophosphatemia or HPP, a dangerous and deadly condition. At Consumer Alert Now, we offer the legal assistance to anyone experiencing any side effects after an Injectafer infusion.
Information about Injectafer
Injectafer is an iron replacement product used to treat iron deficiency anemia. Iron is naturally absorbed from the food that we eat and helps the body produce red blood cells that carry oxygen through the blood to your organs and tissues. Injectafer contains an active drug known as ferric carboxymaltose. The use of Injectafer was adopted after oral iron replacement medicines were tried without success.
Administration of the Drug
Injectafer is injected into the vein through an IV. The drug is given in two doses after seven days. The doctor will determine whether you need to repeat the treatment after the two doses.
You need to tell the caregiver whether you are feeling any swelling, pain, or burning, around the IV needle once injected. The doctor will closely watch for at least thirty minutes after receiving the Injectafer to ensure that there is no allergic reaction to the medication.
You should tell the doctor about any change in weight since the doses are determined based on the patient's weight. To be sure of whether the medicine is helping in your condition, you need to undertake frequent blood tests. You might not notice any changes in your symptoms, but your blood work will help your doctor decide how long you need to be treated using the Injectafer.
Injectafer Dosing Requirement
A patient who intends to use Injectafer should follow a strict dosing requirement to avoid severe side effects. The recommended dosage for patients weighing fifty kilograms(50Kg) or more is two doses separated by a minimum of seven days. You should be given a dosage of 750mg with a total cumulative dose that does not exceed 1500mg of iron for every course.
For patients with less than fifty kilograms(50Kgs), you need to take the drug in two separate doses separated by a minimum of seven days. You should take a dose of 15 mg/ Kg body weight for a total dosage that should not exceed 1500 mg of iron for every course.
Please note, each Injectafer contains about 50 mg of iron.
Preparation and Administration
Injectafer is administered intravenously, which means that it is given as an undiluted slow intravenous push or through an infusion. While it is being administered as an infusion, the doctor should dilute a maximum of 750 mg of iron with a maximum of 250 ml of sterile 0.9% sodium chloride injection, USP, to ensure the concentration infusion is at least 2 mg of iron per Ml. The injection should be administered for at least fifteen minutes.
Once added to the infusion bag with the 0.9% sodium chloride injection, with USP ranging from 2 mg to 4 mg of iron per ML, the Injectafer remains physically and chemically stable for 72 hours if stored at room temperature. To ensure that the stability is maintained, your caregiver should not dilute the concentrations with less than 2 mg of iron per Ml.
Your doctor should inspect whether the drug has any particular matter and discoloration before the administration. The product does not contain any preservatives, and each vial is supposed to be used as a single-dose only.
While the drug is being administered as an intravenous push, you should be given an approximate of 100 mg or 2 Ml every minute. Avoid extravasation of the drug since brown discoloration of the injection site may last for a long time. The doctor should monitor the extravasation, and if it occurs, he or she should discontinue the injection. The unused portion of the drug should be discarded.
Repeating and Monitoring the Treatment for Safety Measures
Injectafer treatment can be repeated if Iron deficiency anemia reoccurs. This is done by monitoring the phosphate level in a patient who is at risk of low serum phosphate and requires a repeat of the treatment course.
In case you miss an appointment, you need to call your doctor for instructions about your Injectafer injection.
In case you overdose, you should seek immediate medical attention or use the Poison Help Line. Symptoms for overdose include joint problems, problems with walking and balance, and weakness.
Information that a Patient Should Tell Your Doctor Receiving Injectafer
Before receiving an Injectafer infusion or injection, you need to tell your doctor about your medical conditions such as:
- Iron allergic reaction once it is given intravenously or through non-oral iron treatment
- High blood pressure
- You are pregnant or planning to become pregnant. Your healthcare provider should decide whether it is safe to take the drug based on his or her assessment on you
- You are planning to breastfeed or breastfeeding. Injectafer can pass into breast milk and would pose an unknown risk to your baby. Talk to your doctor about the best baby feeding procedure after or during Injectafer treatment
You should also tell your doctor about the medication you are taking, including over-the-counter medicines, herbal supplements, and vitamins.
You should also tell your doctor about any of the drugs provided below since they have a negative interaction with Injectafer. These drugs are as follows:
- Vitamin B12
- Vitamin D3
People who experience diseases such as hypertension and hypersensitivity reactions should avoid taking the drug due to its adverse interaction.
Injectafer’s Side Effect
Injectafer is known to cause serious side effects to the patient. It is essential to learn about these side effects to be aware of them once you are injected with the drug. These side effects are as follows:
- Severe allergic reactions - These include life-threatening reactions, loss of consciousness, low blood pressure, and shock. Your healthcare provider should monitor your signs and symptoms after every dose for at least thirty minutes. Other severe allergic reactions include low blood pressure, wheezing, hives, and itching. You should report any signs and symptoms of the above-stated allergic reactions, especially, wheezing, or rashes
- High Blood Pressure – An IDA patient might sometimes experience dizziness, nausea, and flushing of the face during an Injectafer treatment. This can increase your blood pressure, which should resolve within thirty minutes. Your healthcare provider or doctor should monitor these signs and symptoms indicating a rise in blood pressure after every Injectafer dose
The most common side effect experienced after an Injectafer dose include:
- Flushing, low phosphorus level, vomiting, bruising at the point of injection, and dizziness.
- You might also experience long-lasting brow staining at the injection site in case of an Injectefar leak.
Information about Iron Deficiency Anemia
Iron deficiency anemia is a typical kind of anemia. This condition involves the lack of adequate red blood cells in your blood. As the name implies, iron deficiency anemia occurs due to the lack of sufficient iron. Without enough iron, your body cannot produce enough hemoglobin that is used to carry oxygen. The condition might leave you short of breath or tired. You can correct the condition through iron supplementation. However, it is necessary to undertake additional treatment or tests, especially when the doctor suspects any internal bleeding.
Iron Deficiency Anemia Symptoms
Initially, iron deficiency anemia can be mild and can go unnoticed. However, as the body continues to be deficient of iron, this worsens the anemia, and the signs and symptoms might intensify. These signs and symptoms include:
- Headache, lightheadedness, or dizziness
- Cold feet and hands
- Soreness or inflammation of your tongue
- Brittle nails
- An unusual craving for non-nutritive substances such as starch, ice, and dirt
- Poor appetite
You need to see a doctor once you develop the above-stated signs and symptoms that probably suggest Iron Deficiency Anemia. The condition is not something that you can self-diagnose or treat. Therefore, it is essential to seek professional doctor's help rather than taking supplements all by yourself. Overloading your body with iron can be dangerous since once there is excess iron accumulation, this can lead to liver complications.
Causes of Iron Deficiency Anemia
As stated earlier, iron deficiency anemia occurs when your body does not have enough iron to produce hemoglobin. Hemoglobin is responsible for the red color of the red blood cells and also carries oxygenated blood throughout your body.
If you are not consuming enough iron or lose too much iron, the body cannot produce enough hemoglobin leading to iron deficiency anemia. Some of the causes of the condition include:
- Blood Loss – blood contains iron with red blood cells. Therefore, if you lose too much blood, you will be missing some iron. Women who experience heavy periods are at risk of the condition. Also, people who have colorectal cancer or colon polyp, hiatal hernia, and peptic ulcers are at risk of Iron Deficiency Anemia
- Severe lack of Iron in your Diet – Your body gets iron from the food that you eat. Therefore, if you consume food with little or no iron, you might become iron deficient. Examples of iron-rich food that you should consume include leafy green vegetables, iron-fortified foods, eggs, and meat
- Inability to absorb iron – Iron from the food that you eat is absorbed into your bloodstream in your small intestine. However, if you are experiencing an intestinal disorder like celiac disease, this might affect your body's ability to absorb nutrients from digested food. If part of your small intestine has been surgically removed or bypassed, this can affect your ability to absorb iron or any other nutrient
- Pregnancy – Iron deficiency anemia can affect pregnant women if they do not use iron supplements. Pregnant women need iron supplements since they need to serve their increased blood volume and the hemoglobin of the growing fetus.
Some specific people are at risk of Iron deficiency anemia compared to other people. These people are as follows:
- Women – Since women experience loss of blood during menstruation, they are at a higher risk of iron deficiency anemia than men
- Infants and children – Infants, especially those born with low weight or were born prematurely or do not get enough iron from their mothers’ breastmilk, are at risk of iron deficiency anemia. Children need extra iron while growing. Therefore, if your child is not eating a well-balanced diet, he or she might at risk of IDA
- Vegetarians – people who do not eat meat are also at risk of IDA. This might be possible if they do not eat iron-rich foods along with their meat avoidance.
- Frequent blood donors – People who routinely donate their blood are at risk of IDA since blood donation can deplete your iron stores. Low hemoglobin related to blood donation can be temporarily remedied if one eats iron-rich foods. If you are advised not to donate your blood due to low hemoglobin, you should raise this concern to your doctor.
It is hard to experience any complication if you have mild iron deficiency anemia. However, if you are left untreated, this can cause severe health problems such as:
- Heart Problem – Iron deficiency anemia can cause irregular heartbeats. This is due to the increased blood pumping due to the reduced oxygen levels. This can result in heart failure or enlarged heart
- Pregnancy problems – IDA has been connected with low birth weight and premature births. However, if a pregnant woman receives iron supplements as part of the prenatal care, there are less or no chances of developing the condition
- Growth problems- severe deficiency of iron in children and infants can cause delayed growth and development. This also leads to an increased susceptibility to infections
FDA and the Risk Posed by Injectafer
The Food and Drug Administration is responsible for approving any drugs that are meant to be sold within the United States. FDA approved Injectafer, which is manufactured by American Regent, Inc. in July 2013. Even though the drug was approved, there has been a rising concern on its association with hypophosphatemia or HPP.
There were concerns about the drug even before it was approved in 2013. Let's have a closer look at the challenges related to Injectafer before and after its approval.
Non- Approval of the Drug in 2008
American Regent Inc. made the first submission of a new drug application to the FDA in May 2007. They studied that the treatment would work for patients with heavy uterine bleeding and inflammatory bowel disease, compared to iron supplements. They believed that the treatment would work well in such patients since they are required to replenish their iron more quickly compared to how taking pills would take. They also argued that it would be a suitable option for people suffering from inflammatory bowel disease since they cannot tolerate oral supplements.
However, in February 2008, the company announced that FDA had voted that the available data only supported a favorable benefit or risk for treatment of IDA in patients with postpartum or heavy uterine bleeding, but with a restriction to patients who did not respond well to oral iron supplement.
In March 2008, the company announced that the FDA had decided not to approve Injectafer for women experiencing heavy bleeding. According to the FDA, patients taking the drug suffered more adverse events compared to taking iron pills. This includes both mild and severe hypophosphate.
Non- Approval of the Drug in 2011
In October 2011, American Regent Inc. tried again with its drug by submitting a new drug application for its use to treat Iron deficiency anemia. The application included information and data from two new large randomized clinical trials that focused on the cardiovascular risk associated with the drug. One clinical trial focused on patients with IDA and chronic kidney disease while the other compared Injectafer to patients using oral or injection.
In July 2012, the company announced that the FDA had decided to withhold the approval at that time since they found issues related to the American Regent’s manufacturing facilities. However, the company stated that they were working with the agency to resolve these issues.
Approval of the drug in 2013
In July 2013, the FDA approved Injectafer with restriction to patients who could not put up with oral iron supplements and had concerns about its suitability. It was also restricted to patients who are not dependent on dialysis for their chronic kidney disease.
Advertising Concerns of 2014
During the Injectafer advertising of 2014, Luitopold released a promotional video dubbed “The Balancing Act” which was responded with an FDA warning letter about the video script. The two specific statements are as follows:
- “An estimate of 7.5 million people suffer from IDA, and over a third of those are children and women
- “Well, the drug is called Injectafer, and it’s the first intravenous approved drug for IDA patients. It has been approved for patients with oral iron intolerance, unsatisfied with oral iron, or adult patients with chronic kidney disease that do not need dialysis.”
According to the agency, their statement implied that the drug was suitable for all patients suffering from IDA, including children. However, it noted that it was restricted to the three specific adult populations. Therefore, the advertisement was inappropriate since it promoted a product that is "off label" or contrary to the FDA's endorsement.
The agency also noted that the advert did not have enough instructions about the side effects of the drug that would enlighten the public and IDA patients about this. This was followed by criticizing the 30-second segment about the side effect information, which was hard to read since it had small typing.
Hypophosphate Warning added to Drug Label in 2020
With the increased risk of Hypophosphate due to Injectafer, Luitopold finally decided to include a warning label. In response, the warning and precautions about the drug were added in subsection 5.2 of the drug Prescribing Information document.
Injectafer and its Relationship with Severe Hypophosphate Cases
Over time, Injectafer has been associated with an increased risk of Hypophosphate. This is a condition that involves abnormally low levels of phosphate. Severe HPP level is a serious type of this condition and can lead to symptoms such as respiratory failure, hemolytic anemia muscle wasting, and seizure.
In 2016, researchers reported that in 2016, among the patients that were administered with Injectafer, HPP had 45.5%, while severe HPP had prevailed to 32%. These figures were quite high compared with 4% for HPP, and there was no severe HPP in Iron Isomaltoside (IIM).
Not until February 2020, American Regent had failed to give enough warnings about the side effect of Injectafer and had only stated that it might result in moderate side effects such as nausea, headache, and low phosphorus level in the blood. These warnings did not provide enough information about the potential danger and risk of serious HPP. If HPP is left untreated, it might result in:
- Muscle pain
- Fatal arrhythmias
Lawsuits Involving the Risks Posed by Injectafer
Based on the overwhelming evidence about the association of Injectafer with Hypophosphate, the first national lawsuit was filed by Pogust Millrood (Pennsylvania law firm) on behalf of Katherine Crockett. By doing so, the firm tends to hold the pharmaceutical companies, including the manufacturer liable for the pain and suffering that their negligence has inflicted on innocent patient's lives.
Find a Defective Drug Attorney Near Me
Iron Deficiency Anemia patients have been reported to suffer from severe Hypophosphate over time. Once you have suffered from such a condition as a result of your Injectafer intake, you should seek professional legal help while filing a lawsuit against the manufacturer or supplier. Most of the suits are related to the failure to warn about the risk of using their drug.
At the Consumer Alert Now, we give patients a voice and serve as a watchdog on behalf of consumers. If you have experienced any signs and symptoms related to hypophosphate due to your Injectafer intake, contact us today at 800-511-0747 and let us connect you with a lawyer who can help you in your case.