Xgeva: what is it? See indication, side effects and price

Daily, many people need and perform the administration of drugs considered as “high cost” – that is, those who have very high values. Xgeva is one of them.

In the sequence, you will find complete and reliable information about this medication, such as: what it is for, side effects and uses. In addition, see if the drug is generic, what is its price and if SUS provides it.


What is Xgeva?

Xgeva is one of the trade names of the drug whose active ingredient is Denosumab – a drug composed of a protein called monoclonal antibody, which interferes with the action of another protein involved in the activation process of bone degradation.

For this reason, among the indications for this medication, there is the prevention of bone events (bone surgery, for example) and tumor treatment in giant bone cells (in cases where there is no possibility of surgery).

Currently, this remedy is available, and approved by ANVISA (National Health Surveillance Agency), in a subcutaneous injectable version.

In the sequence, understand what are the indications of the medicine, according to the package leaflet:

Indication: what is the medicine Xgeva for?

According to the package leaflet, the drug Xgeva is indicated for the following cases:

  • Treatment of multiple myeloma – a cancer in the plasma cells (type of white blood cell) that has no cure, which causes the disease to sometimes manifest itself and sometimes to go into remission. Almost 100% of patients have bone lesions at diagnosis and more than half suffer pathological fractures * during the course of the disease;
  • Prevent complications in adults with cancer caused by bone metastasis – such as fracture or pressure in the spinal cord. In this case, the medication helps to shrink the tumor and avoids the need for surgery or radiation treatments;
  • Treatment of high levels of calcium in the blood (caused by cancer), after failure of previous treatment with bisphosphonate (a drug class);
  • Treatment of giant cell tumor of the bone – it is a benign bone lesion that reaches the epiphysis (part of the long bone, separated by a layer of cartilage and then joined to the bone). Xgeva is indicated only when surgery cannot be performed or when it is not the best option.

* These are fractures that occur without the need for trauma and can occur anywhere in the body.

This medicine is based on the active ingredient Desonumab. This drug consists of a protein called a monoclonal antibody – its main activity is to interfere with the action of another protein that is part of the bone degradation process.

Xgeva works by reducing the number and function of osteoclasts (cells present in bones and responsible for the breakdown of bone tissue). This results in reduced bone resorption and destruction, processes commonly induced by cancer .

How does the package insert indicate use?

Xgeva is administered through a subcutaneous injection (directly into the adipose tissue, located below the skin) of 120mg.

According to the package insert, the application should be carried out on the thigh, abdomen or arm – once every 4 weeks. It is necessary that the medication be prepared and applied by a qualified health professional.

In addition, the package insert indicates that in cases of treatment due to high blood calcium levels caused by cancer or due to a tumor of giant bone cells, an additional dose is required 1 week and 2 weeks after the first dose.

It is essential to follow the medical recommendations regarding the amount, frequency and duration of treatment with the medication.

Can Xgeva cause side effects?

-Yeah . The drug Xgeva, like any other, can cause side effects to (the) patients who use it.

There are cases in which no adverse reaction manifests itself, but in some others, more than one may appear.

According to the package insert, the most common reactions (occurring in more than 10% of patients) are:

  • Bone, joint or muscle pain;
  • Dyspnea (shortness of breath);
  • Hypocalcemia (low blood calcium).

We can also highlight the common ones (occur in 1% to 10% of patients):

  • Hypophosphatemia (low concentration of phosphate in the blood);
  • Decreased appetite;
  • Persistent pain or non-healing of wounds in the mouth or jaw;
  • Hair loss (alopecia);
  • Back pain;
  • Pain in the jaw;
  • Pain in the extremities (arm or leg);
  • Tiredness;
  • Generalized weakness;
  • Fever;
  • Nausea, vomiting;
  • Diarrhea;
  • Constipation;
  • Increased creatinine (a measure of kidney function) in the blood;
  • Headache;
  • Anemia.

To know about unusual or rare reactions, the ideal is to consult the package leaflet or ask the responsible doctor.

Does ANVISA approve Xgeva?

-Yeah . The drug Xgeva (120mg) has Registration No. 102440009 with ANVISA (National Health Surveillance Agency), characterized as an antineoplastic agent.

Thus, it is approved for use and commercialization as a drug with proven safety and efficacy.

Xgeva and Prolia: what’s the difference?

The medicines Xgeva and Prolia are of the biological type and have the same active ingredient (the substance Denosumab).

Despite this, they are not the same drugs and can not be used for the same purposes. They differ mainly with regard to the directions for use.

As mentioned, the drug Xgeva is indicated for the treatment of multiple myeloma (cancer in plasma cells) and to prevent complications in adults with cancer caused by bone metastasis.

In some cases, it may also be recommended to treat high levels of calcium in the blood (due to cancer) or to treat giant cell tumor of the bone – when surgery is not possible.

The Prolia medicine is indicated for the treatment of:

  • Osteoporosis in pre-menopausal women;
  • Osteoporosis in men;
  • Bone loss in people who have undergone prostate or breast cancer treatments that cause hormonal decrease;
  • Osteoporosis associated with systemic glucocorticoid therapy recently started or sustained (both in men and women).

So, this is the main difference between these remedies. For more information about Prolia, you can consult the package leaflet and seek medical assistance.

Value: what is the price of Xgeva 120mg?

The price * of Xgeva (120mg / 1.7mL) may vary depending on the region and availability of the drug.

In general, the box with 1 ampoule with 1.7mL of solution for subcutaneous use, can cost from R $ 1,750 to R $ 2,040. It is worth remembering that it can only be sold on medical prescription.

* Prices consulted in February 2020. Prices may change.

Generic Xgeva?

No . Xgeva is a biological medication (Amgen laboratory) and therefore there are no generics of it.

As it is a biological remedy, if an alternative version is created, it will also be biological. Currently, there is the medicine Prolia (also biological), which contains the same active ingredient as Xgeva, but does not have the same indications.

It is worth mentioning that, like the reference drugs, biologicals have a patent time – provided due to the investments made to create a new drug.

Therefore, the developer laboratory gains the right to exclusive marketing for a period. So, the formula is only available when the patent time runs out.

However, biological remedies are designed to combat very specific problems. Therefore, it is easier to break with the exclusivity time, as it is good that different versions are produced, in order to have more treatment options.

Does Denosumab have it in SUS?

No . The substance Denosumab does not appear in the National List of Essential Medicines (RENAME) of 2020. Medicines (Xgeva and Prolia) that have this compound as an active ingredient are also not considered to be exceptionally dispensable.

Therefore, it is currently not available through the Unified Health System (SUS).

How to budget Xgeva?

Even when the drug is not supplied by the Federal Government, patients with medical reports can make a judicial request to receive treatment funded by the Unified Health System (SUS) or Health Plan – if applicable.

For this, it is necessary to open a process following the stipulated requests. Among them is the delivery of documents that include, among others:

  • Medical report;
  • Exams;
  • Standard requirement;
  • Budget of 3 pharmacies .

It is possible to count on the assistance of advisors in judicial quotations for the purchase of medicines for the realization of the budget. This consultancy provides a personalized quote and in an easy way.

When accessing the link , just perform the registration, stating some personal data and the medication in question. At the end, click on “request quotes” and wait for the return.

High-cost drugs are a necessity for many people. There are several of them, used for different types of treatments for numerous diseases. As we have seen, Xgeva is a great ally in fighting some of them.